Bright Light Therapy for OSA

Study Overview
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Brief Summary
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Persistent daytime symptoms of sleepiness in individuals with obstructive sleep apnea (OSA) who are using Continuous Positive Airway Pressure (CPAP) are associated with adverse long term medical and functional outcomes. Supplementary exposure to bright light has beneficial effects on sleep quality and daytime vigilance in healthy individuals and it has been increasingly applied in a variety of sleep and neuropsychiatric conditions. This study will explore the role of Bright Light Therapy (BLT), a well-established non-pharmacological intervention for circadian disturbances, for the treatment of residual daytime symptoms of OSA which do not respond to CPAP. BLT will be delivered via therapy glasses in a cross-over design, where each participant will be exposed to active treatment and sham treatment (4 weeks in each arm) in a randomized order. The hypothesis is that participants will demonstrate improvements in the variables of interest during the four-week active treatment portion of the eight-week crossover study, compared to the four-week sham treatment portion.

Detailed Description
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Persistent daytime symptoms of sleepiness in individuals with obstructive sleep apnea (OSA) who are using Continuous Positive Airway Pressure (CPAP) are associated with adverse long term medical and functional outcomes. Supplementary exposure to bright light has beneficial effects on sleep quality and daytime vigilance in healthy individuals and it has been increasingly applied in a variety of sleep and neuropsychiatric conditions. This study will explore the role of Bright Light Therapy (BLT), a well-established non-pharmacological intervention for circadian disturbances, for the treatment of residual daytime symptoms of OSA which do not respond to CPAP. BLT will be delivered via therapy glasses in a cross-over design, where each participant will be exposed to active treatment and sham treatment (4 weeks in each arm) in a randomized order. The hypothesis is that participants will demonstrate improvements in the variables of interest during the four-week active treatment portion of the eight-week crossover study, compared to the four-week sham treatment portion.

Official Title
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Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Other: BLT
* Other: s-BLT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented diagnosis of OSA Currently on CPAP or BiPAP for at least 3 months with documented adherence (defined as wearing CPAP/BiPAP for >6h/night on at least 75% of nights), and adequate control of sleep apnea, as indicated by an AHI of 10 or less when on CPAP Excessive residual daytime sleepiness (Epworth score > 10) If taking alertness promoting medication, the investigators will require that they are on a stable dose for at least one month prior to entering the study and that they refrain from dose changes while participating in the study If already prescribed BLT, subjects must not have used it for at least one month prior to participating Exclusion Criteria: Shift work Travel across time zones in the past month Narcolepsy Regular hypnotics use Decompensated congestive heart failure (CHF) Primary central sleep apnea, needing O2 therapy via nasal cannula Poorly controlled diabetes (HgA1c>8%) Active substance use disorder Dementia Untreated bipolar disorder the investigators will consider individuals with a diagnosis of bipolar disorder who are currently in treatment and stable Macular degeneration, recent lasik surgery (within 3 months) Legally blind Taking medication that will cause photosensitivity to blue-green light spectrum wavelength Already using bright light therapy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: single blind crossover design with randomized condition order
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLT<br>Bright light therapy delivered via glasses | Other: BLT<br>* Bright light therapy delivered via glasses<br>* Other names: Bright light therapy-Active intervention;|
| Sham Comparator: s-BLT<br>Sham Bright light therapy | Other: s-BLT<br>* sham delivered with bright light therapy glasses to which a neutral density filter has been applied<br>* Other names: sham-Bright light therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Epworth sleepiness scale | self report questionnaire assessing daytime drowsiness and tendency to fall asleep if inactive | baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2) | 
| Change in QIDS score | self report assessment of depressive symptoms severity | baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea, CPAP, Residual daytime sleepiness, Depressive symptoms