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Effect and physiological mechanism of bright light on residual sleepiness associated with obstructive sleep apnea

Effect and physiological mechanism of bright light on residual sleepiness associated with obstructive sleep apnea

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081475
Enrollment
Unknown
Registered
2024-03-01
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Interventions

Experimental group:Subjects will receive bright light (10,000 lux) for 1 hour in the morning (8 am to 11 am) and 1 hour in the afternoon (3 PM to 5 PM) for 2 consecutive weeks. The light will be place
Control group:Subjects will receive dark light (<500 lux) for 1 hour in the morning (8 am to 11 am) and 1 hour in the afternoon (3 PM to 5 PM) for 2 consecutive weeks. The light will be placed 0.2-1 m

Sponsors

Sleep Medicine Center, Department of Respiratory and Critical Care Medicine, Mental Health Center, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) 18 years old =65 years old; (2) OSA was diagnosed in the Sleep Medicine Center of West China Hospital of Sichuan University or Respiratory and Critical Care Medicine. Diagnostic criteria for OSA. Interpret sleep apnea/hypopnea events with reference to the American Association of Sleep Physicians (ASSM) Sleep-related Event Interpretation Manual (version 2.3). Apnea is defined as: the presence of airflow down =90% or airflow stop signal, and the duration of not less than 10 seconds; Hypoventilation is defined as a decrease in airflow of =30% for a duration of at least 10 seconds, accompanied by a decrease in oxygen saturation (=3% reduction from baseline levels prior to the respiratory event or presence of a respiratory effort related awakening event on the EEG). AHI is defined as the number of apnea + hypopnea occurrences per hour. The diagnosis of OSA (ICD-10-CM code: G47.33) meets 1) or 2) : 1). Apnea/hypopnea index (AHI) =5 times/hour accompanied by sleepiness, snoring, apnea and other symptoms: 2).AHI=15 times/hour. Central sleep apnea (CSA, ICD-10-CM code: R06.3) was also excluded. CSA was defined as: central apnea + central hypopnea > 5 times per hour, and central apnea + hypopnea accounted for > 50% of all apnea + hypopnea, with or without Cheyne-Stokes breathing; (3) Currently using CPAP or BiPAP, using CPAP/BiPAP for > 3 months, and having good compliance (defined as using CPAP/BiPAP > 4 hours/night at least 70% of the night), while wearing CPAP/BiPAP, residual AHI < 10 times/hour at night; (4) Residual excessive daytime sleepiness (ESS=11 points); (5) Patient health questionnaire Depression Scale PHQ-9: < 5 points.

Exclusion criteria

Exclusion criteria: (1) Shift work, travel across time zones within the past 3 months; (2) Current major mental illness (depression, mania, bipolar affective disorder, etc.); (3) Use of antidepressants, sleeping pills, anti-anxiety drugs, or any other medication for mental illness currently or within the last 3 months; (4) accompanied by narcolepsy and other central somnolence disorders, restless leg syndrome, obesity hypopnea syndrome, central sleep apnea (CSA) and other sleep disorders; (5) Chronic disorders that disrupt the structure of sleep (chronic pain), serious underlying diseases such as uncontrolled acute heart failure, coronary heart disease, chronic obstructive pulmonary disease (COPD), poorly controlled diabetes (HgA1c > 7), poorly controlled hypertension (taking 1 or =2 antihypertensive drugs containing beta blockers, Blood pressure =140/90); (6) Combined with neurodegenerative diseases such as Parkinson's disease and dementia; Vision abnormalities that may affect light therapy, such as glaucoma, macular degeneration, or severe cataracts.

Design outcomes

Primary

MeasureTime frame
Epworth Sleepiness Scale;

Secondary

MeasureTime frame
Adverse reaction;polysomnography (PSG);Multiple sleep latency test;Functional magnetic resonance (brain);24-hour ambulatory blood pressure monitoring;Cognitive function;Sleep diary;Hormone levels, inflammatory factors, liver and kidney function, blood glucose, insulin, etc;

Countries

China

Contacts

Public ContactXiangdong Tang

Sleep Medicine Center, Department of Respiratory and Critical Care Medicine, Mental Health Center, West China Hospital, Sichuan University

2372564613@qq.com+86 28 8542 2825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026