4. Discussion
sleep disorders, sleep disturbance, fatigue, anxiety, daytime sleepiness, sleepiness, insomnia, sleep complaints
PERIODIC LIMB MOVEMENT DISORDER, SLEEP APNEA, DISEASE, RECRUITMENT, REGRESSION
To the best of our knowledge, the present study was the first RCT to examine the effects of FIR-emitting pajamas on sleep in adults with sleep disturbance. The present study showed that the subject recruitment and intervention delivery were feasible. The compliance to intervention was satisfactory, with 35 subjects (87.5%) wearing the pajamas for 36 nights or more. Both FIR-emitting and sham pajamas showed a trend of improving sleep quality, mood, or anxiety symptoms, and the differences between the two were small. Insignificant improvements in physical fatigue and daytime sleepiness were observed in the intervention group compared to the sham-pajamas group, and better MFI-physical scores were recorded for the intervention group specifically. The FIR pajamas were generally safe, as only one subject dropped out in the intervention group because of personal perceived ineffectiveness.The results revealed a non-significant improvement in sleep quality in the sham-pajamas group, who wore pajamas made of ordinary cotton and handmade fibers, but not in the FIR-pajamas group. The improvements observed in the sham-pajamas group can be attributed to the normal progression of the disease, the placebo effects of the sham intervention, and regression to the mean [The sham-pajamas group showed nearly a two-point improvement in the PSQI score and a four-point improvement in the ISI score. The improvements observed in the sham control group can be explained by the normal progression of insomnia and non-specific effects associated with the sham pajamas. First, insomnia symptoms can be self-remitting. A previous local longitudinal study found that as large a proportion as 55.8% of individuals suffering from insomnia experienced remittal at the 1-year follow-up [Though statistically insignificant improvements in physical fatigue and sleepiness were observed, better performance in reducing MFI-physical scores, with large effect sizes at three time points (This study had several limitations in addition to its small sample size. First, this study did not use polysomnography to exclude those with other possible sleep disorders, such as sleep apnea and periodic limb movement disorder, which may also present with sleep complaints. Second, no objective sleep measures, such as actigraphy, were used as outcome measures. Nevertheless, essential subjective sleep assessments [