Evidence of the effectiveness of continuous positive airway pressure in the treatment of sleep apnea/hypopnea syndrome. A randomized crossover study of an oral appliance vs nasal-continuous positive airway pressure in the treatment of mild-moderate obstructive sleep apnea. A short-term controlled trial of an adjustable oral appliance for the treatment of mild to moderate obstructive sleep apnoea. Health utilities in evaluating intervention in the sleep apnoea/hypopnoea syndrome. Effectiveness of CPAP treatment in daytime function in sleep apnea syndrome: a randomized controlled study with an optimized placebo. Ambulatory blood pressure after therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised parallel trial. Positional treatment vs continuous positive airway pressure in patients with positional obstructive sleep apnea syndrome. Cardiovascular effects of continuous positive airway pressure in patients with heart failure and obstructive sleep apnea. Efficacy of positive airway pressure and oral appliance in mild to moderate obstructive sleep apnea. Nasal-CPAP, surgery, and conservative management for treatment of obstructive sleep apnea syndrome. A randomized study. Controlled trial of continuous positive airway pressure in obstructive sleep apnea and heart failure. Effect of nasal continuous positive airway pressure treatment on blood pressure in patients with obstructive sleep apnea. Randomised placebo controlled trial of daytime function after continuous positive airway pressure (CPAP) therapy for the sleep apnoea/hypopnoea syndrome. Randomized placebo-controlled crossover trial of continuous positive airway pressure for mild sleep Apnea/Hypopnea syndrome. Effect of continuous positive airway pressure treatment on daytime function in sleep apnoea/hypopnoea syndrome. Randomised controlled crossover trial of humidified continuous positive airway pressure in mild obstructive sleep apnoea. Ambulatory blood pressure on and off continuous positive airway pressure therapy for the sleep apnea/hypopnea syndrome: effects in "non-dippers". Effect of CPAP therapy on daytime function in patients with mild sleep apnoea/hypopnoea syndrome. Effect of continuous positive airway pressure on sleep architecture in the sleep apnea-hypopnea syndrome: a randomized controlled trial. Mandibular advancement splints and continuous positive airway pressure in patients with obstructive sleep apnoea: a randomized cross-over trial. Randomized crossover trial of two treatments for sleep apnea/hypopnea syndrome: continuous positive airway pressure and mandibular repositioning splint. Randomized placebo-controlled trial of continuous positive airway pressure on blood pressure in the sleep apnea-hypopnea syndrome. An individually adjustable oral appliance vs continuous positive airway pressure in mild-to-moderate obstructive sleep apnea syndrome. Effect of nasal continuous positive airway pressure on neuropsychological function in sleep apnea-hypopnea syndrome. A randomized, placebo-controlled trial.
Continuous positive airway pressure (CPAP) is worldwide considered as the standard treatment of sleep apnea/hypopnea syndrome (SAHS) although studies on the effectiveness of this treatment are limited. The aim of our study was to evaluate the effectiveness of CPAP in improving SAHS-related symptoms, daytime function, perceived health status, and quality of life in patients with moderate to severe SAHS. The effect of conservative treatment (CT) measures-sleep hygiene and weight loss- was compared with CT + CPAP. We included 105 consecutive patients (13 females, age 53 +/- 10 yr, body mass index [BMI] = 32 +/- 6 kg/m2, apnea/hypopnea index [AHI] = 56 +/- 20, Epworth sleepiness scale [ESS] = 12 +/- 5) who met our criteria for CPAP treatment. Patients were randomly allocated in two groups of similar characteristics. Group 1 (n = 37) was asked to improve sleep hygiene and started a weight loss program. Group 2 (n = 68) received, in addition, treatment with CPAP. Both groups were followed through weekly telephone calls and appointments. Sleepiness, other symptoms related to SAHS, daytime function, perceived health status, and quality of life were assessed through questionnaires at inclusion and after 3 mo of treatment. The relief of sleepiness and other SAHS-related clinical symptoms and improvement in perceived health status was much greater in Group 2 receiving CT + CPAP compared with Group 1, only receiving CT. The odds of experiencing a treatment response with CPAP + CT compared with CT alone was 6.52 (odds ratio [OR] = 2.51 to 17.6, 95% confidence interval [95% CI]). CPAP is currently the treatment of choice. At this time, the indication of CPAP treatment in moderate to severe SAHS is adequately supported. To compare efficacy, side effects, patient compliance, and preference between oral appliance (OA) therapy and nasal-continuous positive airway pressure (N-CPAP) therapy.
                Randomized, prospective, crossover study.
                University hospital and tertiary sleep referral center.
                Twenty-seven unselected patients with mild-moderate obstructive sleep apnea (OSA).
                There was a 2-week wash-in and a 2-week wash-out period, and 2 x 4-month treatment periods (OA and N-CPAP). Efficacy, side effects, compliance, and preference were evaluated by a questionnaire and home sleep monitoring.
                Two patients dropped out early in the study and treatment results are presented on the remaining 25 patients. The apnea/hypopnea index was lower with N-CPAP (3.5 +/- 1.6) (mean +/- SD) than with the OA (9.7 +/- 7.3) (p < 0.05). Twelve of the 25 patients who used the OA (48%) were treatment successes (reduction of apnea/hypopnea to <10/h and relief of symptoms), 6 (24%) were compliance failures (unable or unwilling to use the treatment), and 7 (28%) were treatment failures (failure to reduce apnea/hypopnea index to <10/h and/or failure to relieve symptoms). Four people refused to use N-CPAP after using the OA. Thirteen of the 21 patients who used N-CPAP were overall treatment successes (62%), 8 were compliance failures (38%), and there were no treatment failures. Side effects were more common and the patients were less satisfied with N-CPAP (p < 0.005). Seven patients were treatment successes with both treatments, six of these patients preferred OA, and one preferred N-CPAP as a long-term treatment.
                We conclude that OA is an effective treatment in some patients with mild-moderate OSA and is associated with fewer side effects and greater patient satisfaction than N-CPAP. Although oral appliances are effective in some patients with obstructive sleep apnoea (OSA), they are not universally effective. A novel anterior mandibular positioner (AMP) has been developed with an adjustable hinge that allows progressive advancement of the mandible. The objective of this prospective crossover study was to compare efficacy, side effects, patient compliance, and preference between AMP and nasal continuous positive airway pressure (nCPAP) in patients with symptomatic mild to moderate OSA.
                Twenty four patients of mean (SD) age 44.0 (10.6) years were recruited with a mean (SD) body mass index of 32.0 (8.2) kg/m2, Epworth sleepiness score 10.7 (3.4), and apnoea/hypopnoea index 26.8 (11.9)/hour. There was a two week wash-in and a two week wash-out period and two treatment periods (AMP and nCPAP) each of four months. Efficacy, side effects, compliance, and preference were evaluated by a questionnaire and home sleep monitoring.
                One patient dropped out early in the study and three refused to cross over so treatment results are presented on the remaining 20 patients. The apnoea/hypopnoea index (AHI) was lower with nasal CPAP 4.2 (2.2)/hour than with the AMP 13.6 (14.5)/hour (p < 0.01). Eleven of the 20 patients (55%) who used the AMP were treatment successes (reduction of AHI to < 10/hour and relief of symptoms), one (5%) was a compliance failure (unable or unwilling to use the treatment), and eight (40%) were treatment failures (failure to reduce AHI to < 10/hour and/or failure to relieve symptoms). Fourteen of the 20 patients (70%) who used nCPAP were treatment successes, six (30%) were compliance failures, and there were no treatment failures. There was greater patient satisfaction with the AMP (p < 0.01) than with nCPAP but no difference in reported side effects or compliance.
                AMP is an effective treatment in some patients with mild to moderate OSA and is associated with greater patient satisfaction than nCPAP. Formulating a rational health policy necessitates the ability to compare between different healthcare interventions and disease scenarios. Continuous positive airway pressure (CPAP) therapy with a conservative lifestyle strategy in sleep apnoea/hypopnoea syndrome (SAHS) was evaluated using health utility and quality-adjusted life years (QALYs) as outcome measures. A total 71 SAHS (apnoea/hypopnoea index > or = 15 h(-1)) patients completed a randomised, parallel group study over 3 months using utilities derived by the standard gamble approach (Usg) and European quality of life questionnaire (Euroqol) (Ueq). The severely impaired health status at baseline improved by 23% (Usg 0.32 to 0.55) adding 8 QALYs in the CPAP group, compared to a 4% improvement with 4.7 QALYs added in the lifestyle group (Usg 0.31 to 0.35). The Ueq showed a marginal change with CPAP (0.73 to 0.77) but did not demonstrate any improvement with lifestyle intervention. The health status impairment in sleep apnoea/hypopnoea syndrome patients is markedly improved by continuous positive airway pressure compared to a modest improvement with conservative lifestyle strategies using the standard gamble utility, which may be incorporated in effectiveness and economic analyses. The European quality of life questionnaire did not reflect a similar degree of impact and is probably not useful in this population. Application of continuous positive airway pressure (CPAP) as the standard treatment for sleep apnea/hypopnea syndrome (SAHS) is a moot point. Studies on the effectiveness of this treatment have been challenged because of the lack of a suitable placebo. The recent description of a true placebo (sham CPAP) prompted us to conduct a randomized trial of CPAP or placebo to assess the effectiveness of CPAP in improving SAHS-related symptoms and daytime function in patients with moderate to severe SAHS. Forty-eight patients, stratified in four groups according to severity, were randomly allocated into two treatment groups (optimal and sham CPAP) for a 6-wk period. Of these, 45 completed follow-up (91% males; age: 54 +/- 10 yr; body mass index [BMI]: 32 +/- 6 kg/m(2); apnea-hypopnea index [AHI]: 54 +/- 19 events/h; and Epworth Sleepiness Scale [ESS]: 16 +/- 5). The ESS, a questionnaire on SAHS-related symptoms, Functional Outcomes Sleep Questionnaire (FOSQ), and the Short Form Health Survey (SF-36) were completed at inclusion and after treatment. After 10 d of washout, the placebo group was treated with optimal CPAP and reassessed before and after optimal CPAP. The group receiving optimal CPAP when compared with the group with sham CPAP showed considerably greater improvement in the relief of sleepiness (-9.5 versus -2.3, p < 0.001), other SAHS-related symptoms (-18.5 versus -4.5, p < 0.001), vigilance (+8.5 versus +3.4, p = 0.009), and general productivity (+4.0 versus +0.5, p = 0.04) FOSQ scales. Both groups used a similar number of hours for the optimal and the sham CPAP (4.3 versus 4.5, (p = NS). The patients initially treated with placebo CPAP improved significantly more when optimal CPAP was applied for ESS (-2.3 versus -6.7, p < 0.001) and other sleep apnea syndrome (SAS)-related symptoms (-4.5 versus -11.2, p = 0.02). Our study provides strong evidence of the effectiveness of CPAP treatment in improving symptoms and perceived health status in moderate to severe SAHS. Obstructive sleep apnoea is associated with raised blood pressure. If blood pressure can be reduced by nasal continuous positive airway pressure (nCPAP), such treatment could reduce risk of cardiovascular disease in patients with obstructive sleep apnoea. Our aim was to see whether nCPAP for sleep apnoea reduces blood pressure compared with the most robust control intervention subtherapeutic nCPAP.
                We did a randomised parallel trial to compare change in blood pressure in 118 men with obstructive sleep apnoea (Epworth score > 9, and a > 4% oxygen desaturation index of > 10 per h) who were assigned to either therapeutic (n=59) or subtherapeutic (59) nCPAP (about 1 cm H(2)O pressure) for 1 month. The primary outcome was the change in 24-h mean blood pressure. Secondary outcomes were changes in systolic, diastolic, sleep, and wake blood pressure, and relations between blood pressure changes, baseline blood pressure, and severity of sleep apnoea.
                Therapeutic nCPAP reduced mean arterial ambulatory blood pressure by 2.5 mm Hg (SE 0.8), whereas subtherapeutic nCPAP increased blood pressure by 0.8 mm Hg (0.7) (difference -3.3 [95% CI -5.3 to -1.3]; p=0.0013, unpaired t test). This benefit was seen in both systolic and diastolic blood pressure, and during both sleep and wake. The benefit was larger in patients with more severe sleep apnoea than those who had less severe apnoea, but was independent of the baseline blood pressure. The benefit was especially large in patients taking drug treatment for blood pressure.
                In patients with most severe sleep apnoea, nCPAP reduces blood pressure, providing significant vascular risk benefits, and substantially improving excessive daytime sleepiness and quality of life. The aim of this study was to compare the relative efficacy of continuous positive airway pressure (CPAP) and positional treatment in the management of positional obstructive sleep apnea (OSA), using objective outcome measures.
                A prospective, randomized, single blind crossover comparison of CPAP and positional treatment for 2 weeks each.
                A university teaching hospital.
                Thirteen patients with positional OSA, aged (mean+/-SD) 51+/-9 years, with an apnea-hypopnea index (AHI) of 17+/-8.
                (1) Daily Epworth Sleepiness Scale scores; (2) overnight polysomnography, an objective assessment of sleep quality and AHI; (3) maintenance of wakefulness testing; (4) psychometric test battery; (5) mood scales; (6) quality-of-life questionnaires; and (7) individual patient's treatment preference.
                Positional treatment was highly effective in reducing time spent supine (median, 0; range, 0 to 32 min). The AHI was lower (mean difference, 6.1; 95% confidence interval [CI], 2 to 10.2; p = 0.007), and the minimum oxygen saturation was higher (4%; 95% CI, 1% to 8%; p = 0.02) on CPAP as compared with positional treatment. There was no significant difference, however, in sleep architecture, Epworth Sleepiness Scale scores, maintenance of wakefulness testing sleep latency, psychometric test performance, mood scales, or quality-of-life measures.
                Positional treatment and CPAP have similar efficacy in the treatment of patients with positional OSA. Obstructive sleep apnea subjects the failing heart to adverse hemodynamic and adrenergic loads and may thereby contribute to the progression of heart failure. We hypothesized that treatment of obstructive sleep apnea by continuous positive airway pressure in patients with heart failure would improve left ventricular systolic function.
                Twenty-four patients with a depressed left ventricular ejection fraction (45 percent or less) and obstructive sleep apnea who were receiving optimal medical treatment for heart failure underwent polysomnography. On the following morning, their blood pressure and heart rate were measured by digital photoplethysmography, and left ventricular dimensions and left ventricular ejection fraction were assessed by echocardiography. The subjects were then randomly assigned to receive medical therapy either alone (12 patients) or with the addition of continuous positive airway pressure (12 patients) for one month. The assessment protocol was then repeated.
                In the control group of patients who received only medical therapy, there were no significant changes in the severity of obstructive sleep apnea, daytime blood pressure, heart rate, left ventricular end-systolic dimension, or left ventricular ejection fraction during the study. In contrast, continuous positive airway pressure markedly reduced obstructive sleep apnea, reduced the daytime systolic blood pressure from a mean (+/-SE) of 126+/-6 mm Hg to 116+/-5 mm Hg (P=0.02), reduced the heart rate from 68+/-3 to 64+/-3 beats per minute (P=0.007), reduced the left ventricular end-systolic dimension from 54.5+/-1.8 to 51.7+/-1.2 mm (P=0.009), and improved the left ventricular ejection fraction from 25.0+/-2.8 to 33.8+/-2.4 percent (P<0.001).
                In medically treated patients with heart failure, treatment of coexisting obstructive sleep apnea by continuous positive airway pressure reduces systolic blood pressure and improves left ventricular systolic function. Obstructive sleep apnea may thus have an adverse effect in heart failure that can be addressed by targeted therapy. The efficacy of currently recommended treatments is uncertain in patients with mild to moderate obstructive sleep apnea (apnea-hypopnea index [AHI], 5-30). A group of 114 sleep clinic patients with an AHI of 5-30 have participated in a randomized controlled crossover trial of 3 months of treatment with each of nasal continuous positive airway pressure (CPAP), a mandibular advancement splint, and a placebo tablet. Outcomes were sleep fragmentation and hypoxemia, daytime sleepiness, quality of life, neurobehavioral function, and blood pressure. Both active treatments improved sleep outcomes, but positive airway pressure had a greater effect. The quality of life, symptoms, and subjective but not objective sleepiness improved to a similar degree with both treatments; however, many of the improvements seen in neuropsychologic function and mood were not better than the placebo effect. Some aspects of nocturnal blood pressure were improved with the splint but not with CPAP. This study has shown that although both CPAP and mandibular advancement splint effectively treated sleep-disordered breathing and sleepiness, the expected response in neurobehavioral function was incomplete. This may be due to the splint having a lesser therapeutic effect and CPAP being poorly tolerated and therefore used less in this patient group. To assess separately the effectiveness and safety of nasal-continuous positive airway pressure (N-CPAP) and that of surgery in comparison to conservative management in patients with obstructive sleep apnea syndrome (OSAS). DESIGN. A randomized study with 1-year follow-up.
                A university hospital acting as a referral center for OSAS.
                Symptomatic patients with OSAS (72 male and 4 female patients aged 18 to 65 years), who had oxygen desaturations in the overnight recording.
                After the initial diagnostic workup, patients were considered to be candidates for either N-CPAP (44 patients) or surgical treatment (uvulopalatopharyngoplasty [UPPP] with or without mandibular osteotomy) (32 patients). Within the groups, the patients were then randomized to either the assigned treatment or conservative management.
                The number of nocturnal oxygen desaturation events of 4% or more per hour in bed (ODI4); daytime somnolence; side effects.
                N-CPAP Group: Compliance with N-CPAP therapy at 1 year was 13 of 21. The most common reason for noncompliance was general intolerance of CPAP. All compliant patients had a normal ODI4 ( < 10), whereas 1 of 20 of their control subjects had a normal finding. Patients receiving active treatment were significantly less somnolent than their control subjects at 1 year (p < 0.05). SURGERY GROUP: At 1 year, 7 of 18 of the surgically treated and 1 of 14 of the conservatively treated patients had a normal ODI4 (p < 0.001). Daytime somnolence was significantly less severe in the surgically treated patients compared with their control subjects (p < 0.001) both at 3 and 12 months. The overall postoperative complication rate was 22%.
                N-CPAP is an effective therapy for OSAS, but compliance is a problem. Surgical therapy (UPPP with or without mandibular osteotomy) needs further evaluation. Obstructive sleep apnea (OSA) is highly prevalent among patients with congestive heart failure (CHF) and may contribute to progression of cardiac dysfunction via hypoxia, elevated sympathetic nervous system activity, and systemic hypertension. Our aim was to assess the long-term effect of OSA treatment with nocturnal continuous positive airway pressure (CPAP) on systolic heart function, sympathetic activity, blood pressure, and quality of life in patients with CHF. Fifty-five patients with CHF and OSA were randomized to 3 months of CPAP or control groups. End points were changes in left ventricular ejection fraction, overnight urinary norepinephrine excretion, blood pressure, and quality of life. Nineteen patients in the CPAP group and 21 control subjects completed the study. Compared with the control group, CPAP treatment was associated with significant improvements in left ventricular ejection fraction (delta 1.5 +/- 1.4% vs. 5.0 +/- 1.0%, respectively, p = 0.04), reductions in overnight urinary norepinephrine excretion (delta 1.6 +/- 3.7 vs. -9.9 +/- 3.6 nmol/mmol creatinine, p = 0.036), and improvements in quality of life. There were no significant changes in systemic blood pressure. In conclusion, treatment of OSA among patients with CHF leads to improvement in cardiac function, sympathetic activity, and quality of life. There is increasing evidence that obstructive sleep apnea (OSA) is an independent risk factor for arterial hypertension. Because there are no controlled studies showing a substantial effect of nasal continuous positive airway pressure (nCPAP) therapy on hypertension in OSA, the impact of treatment on cardiovascular sequelae has been questioned altogether. Therefore, we studied the effect of nCPAP on arterial hypertension in patients with OSA.
                Sixty consecutive patients with moderate to severe OSA were randomly assigned to either effective or subtherapeutic nCPAP for 9 weeks on average. Nocturnal polysomnography and continuous noninvasive blood pressure recording for 19 hours was performed before and with treatment. Thirty two patients, 16 in each group, completed the study. Apneas and hypopneas were reduced by approximately 95% and 50% in the therapeutic and subtherapeutic groups, respectively. Mean arterial blood pressure decreased by 9.9+/-11.4 mm Hg with effective nCPAP treatment, whereas no relevant change occurred with subtherapeutic nCPAP (P=0.01). Mean, diastolic, and systolic blood pressures all decreased significantly by approximately 10 mm Hg, both at night and during the day.
                Effective nCPAP treatment in patients with moderate to severe OSA leads to a substantial reduction in both day and night arterial blood pressure. The fact that a 50% reduction in the apnea-hypopnea index did not result in a decrease in blood pressure emphasizes the importance of highly effective treatment. The drop in mean blood pressure by 10 mm Hg would be predicted to reduce coronary heart disease event risk by 37% and stroke risk by 56%. Patients with the sleep apnoea/hypopnoea syndrome (SAHS) report improved sleepiness, cognitive function, and psychological well being after continuous positive airway pressure (CPAP) therapy, and it is for these daytime features that CPAP is usually given. However, few randomised or controlled studies exist on the effects of CPAP on daytime function.
                A prospective, randomised, single blind, placebo controlled, crossover trial of daytime function after CPAP was conducted in 23 patients with SAHS, all with > or = 15 apnoeas + hypopnoeas/hour and > or = 2 symptoms of SAHS. All patients spent four weeks on CPAP therapy and four weeks on oral placebo treatment, following randomisation to treatment order. With ethics committee approval, patients were told the placebo tablet might improve upper airway function. Average effective CPAP use was monitored using hidden time clocks. Assessments of objective and subjective sleepiness, symptoms, cognitive performance, and psychological well being were performed on the last day of each treatment and compared.
                Objective sleepiness measured by sleep onset latency on the multiple sleep latency test improved with CPAP (mean difference from placebo +2.4 min, 95% CI 0.8 to 4.0; p < 0.001) as did subjective sleepiness on the Epworth scale (mean difference -6, 95% CI -3 to -9; p = 0.001). Symptom total score also fell with CPAP (mean difference -1.6, 95% CI -2.2 to -1.0; p < 0.001). No determinants of these changes with active treatment were identified, and no significant enhancements to cognitive function or psychosocial well being were found in this small sample.
                These findings provide further evidence for clinically significant benefits to daytime function from CPAP. The minimal disease severity at which patients with the sleep apnea/hypopnea syndrome (SAHS) gain benefit from treatment is not well characterized, although a pilot study of continuous positive airway pressure (CPAP) therapy showed daytime improvements in patients with 5 to 15 apneas + hypopneas per hour slept (AHI). We have thus performed a second, larger, randomized, placebo- controlled study in a prospective series of 34 patients (13 female) with mild SAHS (AHI 5 to 15) and daytime sleepiness. Patients spent 4 wk on CPAP treatment and 4 wk on an oral placebo, with randomization of treatment order, and daytime assessments on the last day of each treatment. Effective CPAP use averaged 2.8 +/- 2.1 h (mean +/- SD) per night. Compared with placebo, CPAP improved symptom score (p < 0.01), subjective (Epworth; p < 0.01) but not objective (maintenance of wakefulness test; p > 0.2) sleepiness, performances on 2 of 7 cognitive tasks (p < 0.02), depression score (p < 0.01), and five subscales of the SF-36 health/functional status questionnaire (p </= 0.03). Fourteen of 34 patients preferred CPAP. In 14 patients with AHI in the range 5 to 10, symptoms, cognitive function, psychological well-being and quality of life were improved. These results confirm benefits for daytime function after CPAP treatment for mild SAHS, but highlight unacceptability of CPAP in many such patients. Continuous positive airway pressure (CPAP) is the treatment of choice for the sleep apnoea/hypopnoea syndrome (SAHS); it is usually given with the aim of improving daytime cognitive function, mood, and sleepiness. However, its efficacy has not been validated by controlled trials. We have carried out a randomised, placebo-controlled, crossover study of objective daytime sleepiness, symptoms, cognitive function, and mood in a consecutive series of 32 SAHS patients with a median apnoea plus hypopnoea frequency of 28 (range 7-129) per hour slept. Patients were treated with 4 weeks each of CPAP and an oral placebo, which they were told might improve upper airway muscle function during sleep. Assessments on the last day of each treatment included a multiple sleep latency test and tests of symptom scores, mood profiles, and cognitive performance. The patients had significantly less daytime sleepiness on CPAP than during the placebo period (mean sleep latency 7.2 [SE 0.7] vs 6.1 [0.7] min, p = 0.03). There were also improvements with CPAP in symptom ratings (2.1 [0.2] vs 4.3 [0.3], p < 0.001), mood (p < 0.05 for several measures), and cognitive performance, which showed improved vigilance (obstacles hit in Steer Clear "driving" test 76 [5] vs 81 [6], p < 0.01), mental flexibility (trail-making B time 66 [5] vs 75 [5] s, p < 0.05), and attention (p < 0.05). Objectively monitored CPAP use averaged only 3.4 (0.4) hours per night, but this study provides evidence of improved cognitive performance even at this low level of CPAP compliance. It is unclear whether continuous positive airway pressure (CPAP), the treatment of choice for severe obstructive sleep apnoea (OSA), is effective at improving outcomes in mild OSA.
                To help define the role of humidified CPAP in mild OSA, a randomised crossover study was undertaken of patients with an apnoea hypopnoea index (AHI) of 5-30/hour. Subjective sleepiness, objective wakefulness, mood, reaction time, and quality of life were measured at baseline, after 3 weeks treatment with humidified CPAP and 3 weeks sham CPAP (2 week washout).
                Twenty nine of 31 enrolled patients (age 25-67 years, seven women, mean (SD) body mass index 31.5 (6) kg/m2) completed the protocol. Humidified CPAP improved polysomnographic indices of OSA and Epworth Sleepiness Scale (2.4 points (95% CI 0.6 to 4.2)). Objective wakefulness (modified maintenance of wakefulness test) showed a trend towards improvement (5.2 minutes (95% CI -0.6 to 11)). Mood (Hospital Anxiety and Depression Scale), quality of life (SF 36, Functional Outcomes of Sleep Questionnaire), and reaction times (Psychomotor Vigilance Task) were not improved more than sham CPAP. Compliance with humidified and sham CPAP both averaged 4.9 hours/night. Placebo effects were evident in many outcomes and there was no clear treatment preference.
                Humidified CPAP improves subjective sleepiness and possibly objective wakefulness but not reaction times, quality of life, or mood. These results do not support the routine use of CPAP in all patients with mild OSA, but offers some support for the trialling of CPAP in those with severe sleepiness. Ambulatory blood pressure (BP) monitoring was performed in 13 patients with the sleep apnea/ hypopnea syndrome (SAHS) during a randomized, placebo controlled crossover trial of the effects of continuous positive airway pressure (CPAP) therapy. BP was monitored at half-hourly intervals for a 24-hour period both on CPAP and on an oral placebo, each given for a minimum of 3 weeks. Objective effective CPAP use averaged 4.3 hours per night. Weight and anti-hypertensive medications remained stable over the study period. Systolic, diastolic and mean arterial BP for 24-hour, daytime and nighttime periods were not significantly different on placebo compared to CPAP. Those patients with no significant overnight fall in BP on placebo ("non-dippers") showed a significant improvement in daytime mean arterial BP on CPAP (98 +/- 4 mm Hg) compared to placebo (102 +/- 4 mm Hg; p = 0.01). These findings, in a well-controlled trial, suggest that BP is not reduced by CPAP in a heterogeneous group of SAHS patients, but it may be selectively improved in those patients most at risk for cardiovascular morbidity and mortality. Continuous positive airway pressure (CPAP) is an effective treatment in patients with moderate and severe sleep apnoea/hypopnoea syndrome (SAHS), but the minimum illness severity at which patients obtain benefit from CPAP is unclear. A study was therefore undertaken to investigate whether CPAP improves symptoms and daytime function in patients with mild SAHS.
                Sixteen consecutively recruited patients with mild SAHS (5.0-14.9 apnoeas + hypopnoeas per hour slept and two or more symptoms of SAHS) participated in a prospective placebo controlled randomised crossover trial to assess the effects of CPAP on symptoms and daytime function. Patients spent four weeks on placebo and four weeks on CPAP, undergoing assessments of sleepiness, symptoms, cognitive performance, and well being on the last day of each treatment. Data from the placebo and CPAP assessments were compared.
                The mean (SE) objective effective use of CPAP was 2.8 (0.7) hours per night. Significant improvements in symptom score (-1.7 (0.5), p < 0.01), mental flexibility (-14 (5) seconds, p = 0.02), and depression rating (-1.6 (0.8), p = 0.03) on CPAP were observed. However, no significant differences in subjective or objective sleepiness were found. Ten of the 16 patients preferred CPAP and opted to continue with this treatment, although this proportion was non-significant (p > 0.4). The eight patients with best CPAP use showed an additional CPAP related improvement in quality of life (-4.4 (1.8), p = 0.03). Those who complied better with CPAP therapy also had a higher average microarousal frequency (p < 0.01) and apnoea+hypopnoea index (p = 0.02) than the poorer compliers.
                The results of this study provide evidence for improvements in symptoms and daytime function for patients with mild SAHS treated with CPAP. There is randomized controlled evidence that patients with sleep apnea-hypopnea syndrome (SAHS) treated with continuous positive airway pressure (CPAP) have improved daytime function and quality of life. "Before-and-after" data indicate that CPAP improves sleep quality, but there is no randomized controlled evidence of this. We tested the hypothesis that CPAP improved sleep quality in patients with SAHS. We also sought correlations between polysomnographic (PSG) indices and benefit from use of CPAP. Twenty-two patients with SAHS (median, [interquartile range] apnea-hypopnea index, 40 [25-65] events/h) spent 1 mo receiving CPAP and 1 mo receiving placebo capsules, in random order, and home sleep studies were performed at the end of each month. CPAP resulted in a lower arousal index, less Stage 1, and more Stage 3+4 sleep, but there was no increase in Stage REM (rapid eye movement) sleep. Improvement in Epworth score after 6-12 mo of treatment correlated significantly with PSG indices on CPAP: sleep efficiency index (r = 0.78, p < 0.001), Stage REM (r = 0.55, p = 0.001), Stage 3+4 (r = 0.5, p = 0.02), and arousal index (r = -0.43, p = 0.05). This study provides randomized controlled trial evidence that patients with SAHS sleep better when receiving CPAP. Patients with good sleep quality on CPAP at 1 mo are likely to gain later benefit in subjective daytime sleepiness. This prospective, randomized, cross-over trial was designed to compare the efficacy of a mandibular advancement splint (MAS) with that of nasal continuous positive airway pressure (nCPAP) in patients with obstructive sleep apnoea (OSA). Twenty-four patients (20 males and four females) with mild to moderate OSA (AHI between 10 and 49 events per hour) were enrolled in the study. Each patient used both MAS and nCPAP, with the initial therapy being allocated at random. Treatment periods lasted for two months with a two-week wash-out interval between. Polysomnography was performed prior to the study and after each clinical intervention. Patient and partner questionnaires were used to assess changes in general health and daytime somnolence. The AHI decreased from 22.2 to 3.1 using nCPAP, and to 8.0 using the MAS (P < 0.001 for both devices) and there was no statistically significant difference between the two treatments. The Epworth Sleepiness Score (ESS) fell from 13.4 to 8.1 with nCPAP, and to 9.2 with MAS (P < 0.001), again with no differences between the use of MAS or nCPAP. The questionnaire data showed an improvement in general health scores (P < 0.001) after both treatments, but daytime sleepiness only improved significantly using nCPAP (P < 0.001). Despite this, 17 out of the 21 subjects who completed both arms of the study preferred the MAS. The splints were well tolerated and their efficacy suggests that the MAS may be a suitable alternative to nCPAP in the management of patients with mild or moderate OSA. Mandibular repositioning splints (MRSs) and continuous positive airway pressure (CPAP) are used to treat the sleep apnea/hypopnea syndrome (SAHS). There are some data suggesting that patients with milder symptoms prefer MRS, but there are few comparative data on outcomes. Therefore, we performed a randomized crossover trial of 8 weeks of CPAP and 8 weeks of MRS treatment in consecutive new outpatients diagnosed with SAHS (apnea/hypopnea index [AHI] >or= 5/hour, and >or= 2 symptoms including sleepiness). Assessments at the end of both limbs comprised home sleep study, subjective ratings of treatment value, sleepiness, symptoms, and well-being, and objective tests of sleepiness and cognition. Forty-eight of 51 recruited patients completed the trial (12 women; age [mean +/- SD], 46 +/- 9 years; Epworth 14 +/- 4; median AHI, 22/hour; interquartile ratio [IQR], 11-43/hour). Significant (p <or= 0.01) differences between MRS and CPAP were observed for 7 of 21 variables (effect sizes, 0.3-0.6 SDs), all favoring CPAP, including AHI (15 +/- 16 and 8 +/- 6/hour, respectively), effectiveness rating, symptoms, Epworth (12 +/- 5 and 8 +/- 5, respectively), functional outcomes of sleepiness questionnaire, short-form 36 health survey mental component, and health transition scores. Objective sleepiness, cognitive performance, and preference for treatments were not different. In patients experiencing a mild form of the syndrome (AHI < 15, n = 18), symptoms, treatment efficacy and satisfaction, and subjective sleepiness were also better with CPAP than with MRS (effect sizes, 0.7-1.1 SDs). These results do not support these MRS devices as first-line treatment for sleepy patients with SAHS. Arterial blood pressure rises at apnea termination, and there is increasing evidence that the sleep apnea-hypopnea syndrome (SAHS) is associated with daytime hypertension but no randomized controlled trial evidence of whether SAHS treatment reduces blood pressure exists. We, therefore, conducted a randomized placebo-controlled cross-over study of the effects of 4 wk of continuous positive airway pressure (CPAP) or oral placebo on 24-h blood pressure in 68 patients (55 males, 13 females; median apnea-hypopnea index [AHI], 35) not receiving hypotensive medication. Ambulatory blood pressure was recorded for the last 48 h of each treatment. Epworth Sleepiness Score (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ) were also recorded. All patients were normotensive. There was a small decrease in 24-h diastolic blood pressure (placebo, 79.2 [SE 0.9] mm Hg; CPAP, 77.8 [SE 1.0] mm Hg; p = 0.04) with the greatest fall occurring between 2:00 A.M. and 9:59 A.M. The observed decrease in 24-h diastolic blood pressure was greater in two a priori groups, CPAP use > or = 3.5 h per night (81.5 [SE 1.2] mm Hg; 79.6 [SE 1.2] mm Hg; p = 0.03) and those with more than twenty 4% desaturations per hour (82.4 [SE 2.1] mm Hg; 77.4 [SE 2.1] mm Hg; p = 0.002). Systolic pressure also fell in the latter group (133.1 [SE 2.8] mm Hg; 129.1 [SE 2.1] mm Hg; p = 0.009). Desaturation frequency was the best predictor of diastolic blood pressure fall with CPAP (r = 0.38; p = 0.002). Both ESS and FOSQ domains improved. Thus, CPAP can reduce blood pressure in patients with SAHS, particularly in those with nocturnal oxygen desaturation, but the decrease is small. For the treatment of nonsevere obstructive sleep apnea syndrome (OSAS), mandibular advancement devices (MADs) are employed as an alternative to nasal continuous positive airway pressure (CPAP) therapy. However, very few specific data on the effectiveness of MADs in this group of patients are available. We therefore compared an individually adjustable intraoral sleep apnea device (ISAD) that permits movements of the lower jaw in three dimensions, with CPAP in the treatment of patients with an apnea/hypopnea index (AHI) < or = 30/h.
                In a randomized crossover study, 16 men and 4 women (mean +/- SD age, 56.5 +/- 10.2 years; body mass index, 31.2 +/- 6.4; AHI, 17.5 +/- 7.7/h) were treated for 6 weeks with each modality.
                In the initial phase, a significant improvement in AHI (baseline, 17.5 +/- 7.7/h; ISAD, 10.5 +/- 7.5/h [p < 0.05]; CPAP, 3.5 +/- 2.9/h [p < 0.01]) and in breathing-related arousals (baseline, 8.9 +/- 6.1/h; ISAD, 3.7 +/- 3.3/h [p < 0.01]; CPAP, 1.4 +/- 1.6/h [p < 0.01]) was achieved with both modalities. Considering all 20 subjects, after 6 weeks of treatment, normalization of the respiratory parameters was seen only with CPAP. However, 30% of the patients had a lasting reduction in AHI to < 10/h with the ISAD also. The patients considered the ISAD to be easier to use (scale of 1 to 6: ISAD, 1.8 +/- 1.1; CPAP, 3.1 +/- 1.5 [p < 0.05]), and indicated greater utilization of the device in comparison with CPAP.
                Even in patients with mild-to-moderate OSAS, CPAP is the more effective long-term treatment modality. In the individual case, the better compliance seen with the ISAD may be advantageous. A placebo-controlled, partial cross-over, double-blind, randomized study was performed with 46 adults with sleep apnea-hypopnea syndrome (SAHS) to determine the effect of therapeutic and subtherapeutic (0-1 cm H(2)O) nasal continuous positive airway pressure (CPAP) treatment on polysomnographic and neuropsychological testing. The following neuropsychological tests were administered: Geriatric Depression Scale, Trail Making A and B, Digit Span Test Forward and Backward, Epworth Sleepiness Scale, SteerClear, Digit Symbol, Controlled Oral Word Association, and Complex Figure Recall. Compared with results without CPAP, subtherapeutic CPAP did not affect any measured polysomnographic parameter. Comparison of neuropsychological test results obtained between the initial periods of effective treatment (Group 1, 16.1 d; Group 2, 19.6 d; p = NS) in all subjects showed significant improvements in Digit Symbol, Digit Span Backward, and Complex Figure tests. However, there were no group differences in changes in test results during the period when one group was on effective CPAP and the other on ineffective CPAP (Group 1, 16.1 d; Group 2, 13.9 d; p = NS). The results indicate the feasibility and importance of using ineffective CPAP as a placebo treatment and the importance of including a placebo control in studies evaluating the effect of treatment on neuropsychological function in SAHS.
CPAP is effective in reducing symptoms of sleepiness and improving quality of life measures in people with moderate and severe obstructive sleep apnoea (OSA). It is more effective than oral appliances in reducing respiratory disturbances in these people but subjective outcomes are more equivocal. Certain people tend to prefer oral appliances to CPAP where both are effective. This could be because they offer a more convenient way of controlling OSA. Short-term data indicate that CPAP leads to lower blood pressure than control. Long-term data are required for all outcomes in order to determine whether the initial benefits seen in short-term clinical trials persist.