2.1. Study Design and Patients
distress or impairment, hypersomnolence disorder, sleep disorders, sleep disorder, narcolepsy, psychiatric illness, primary insomnia disorder, psychiatric, insomnia, mental disorders, DSM-5
NARCOLEPSY, SLEEP-RELATED HYPOVENTILATION, MAY, PRIMARY INSOMNIA, CENTRAL SLEEP APNEA
This study was a pilot, randomized, open-label, two-arm clinical trial that was conducted over a period of two weeks. The study protocol was approved by the Institutional Review Board of Yongin Severance Hospital (IRB No. 9-2022-0025) (date of approval: 30 March 2022) and registered at the Clinical Research Information Service (CRIS, KCT0007293) (date of registration: 17 May 2022). This study was conducted in compliance with the principles of the Declaration of Helsinki. Informed consent was obtained from all subjects. Patients were recruited from 18 April to 27 June 2022, at Yongin Severance Hospital (Yongin, Republic of Korea). We recruited individuals who sought medical care at a primary care clinic due to persistent sleep problems lasting more than three months, which caused significant distress or impairment in their daily functioning. We specifically focused on primary insomnia, a chronic sleep disorder characterized by difficulties in initiating or maintaining sleep, or experiencing non-restorative sleep, without any underlying medical, psychiatric, or environmental causes. The exclusion criteria were as follows: sleep disorders included in the DSM-5, except for primary insomnia disorder (e.g., hypersomnolence disorder, narcolepsy, obstructive sleep apnea hypopnea, central sleep apnea, sleep-related hypoventilation, etc.), sleep disorders related to other mental disorders, sleep disorders related to other medical conditions, history of psychiatric illness, and patients starting other treatments for insomnia within three months. Only individuals who were taking sleep medication without altering the type or dosage during the trial period were included in the study. We also excluded individuals who were shift workers or had traveled through more than two time zones within the past month.