Sleep disorder
Conditions
Interventions
Obstructive Sleep Apnea Group-Experimental group:Anti-Snoring Pillow and Intelligent Closed-Loop Intervention
Obstructive Sleep Apnea Group-Control group:Mild-to-Moderate OSA: Portable Sleep Monitoring Device Alone
Severe OSA: Continuous Positive Airway Pressure (CPAP) Therapy combined Concurrent Portable Sle
Co-Morbid Insomnia and Sleep Apnea group-Experimental group:Snore-Suppressing Pillow and eCBT-I and Intelligent Closed-Loop Intervention
Co-Morbid Insomnia and Sleep Apnea group-Control group:Continuous Positive Airway Pressure (CPAP) Therapy and eCBT-I and Concurrent Portable Sleep Monitoring
Insomnia-Experimental group:eCBTI combined Intelligent Closed-Loop Wearable Diagnosis and Intervention System for Insomnia
Insomnia-Control group:eCBTI combined Concurrent Portable Sleep Monitoring
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for OSA and COMISA Groups (All 3 criteria must be met): 1.Age between 30 and 70 years (exclusive). 2.Diagnosis of OSA: Confirmed mild-to-moderate OSA (apnea-hypopnea index, AHI, 5–30 events/hour) or severe OSA (AHI > 30 events/hour), accompanied by symptoms of snoring. 3.Provision of signed informed consent, with willingness and ability to comply with the study protocol (e.g., understanding and completing questionnaires, adhering to scheduled visits). Inclusion Criteria for Insomnia Group (All 4 criteria must be met): 1.Age >= 40 years. 2.Diagnosis of chronic insomnia according to ICSD-3 criteria, with complaints of sleep maintenance difficulty or subjective poor sleep quality, and an Insomnia Severity Index (ISI) score > 10. 3.Educational attainment at or above the primary school level, enabling independent completion of questionnaires. 4.Provision of signed informed consent, with willingness and ability to comply with the study protocol.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for OSA and COMISA Groups (Exclusion if any one of the following criteria is met): 1.Total sleep time < 4 hours. 2.Inability to complete required questionnaires. 3.Inability to cooperate with polysomnography (PSG) examination. Exclusion Criteria for Insomnia Group (Exclusion if any one of the following criteria is met): 1.Comorbid with other sleep disorders (e.g., restless legs syndrome, narcolepsy). 2.Presence of severe systemic diseases, such as severe hepatic, renal, or cardiac dysfunction, or malignancy. 3.Lack of access to a mobile phone or inability to use a designated application. 4.Current use of sleep-promoting medications. 5.Concurrent participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Apnea-Hypopnea Index (AHI) Before and After Treatment;Alterations in Macro-Architectural Parameters of Sleep; | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaire; | — |
Countries
China
Contacts
Public ContactZhang Ning
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed