NCT05917119 · VA Office of Research and Development
Bright Light Therapy for OSA
(BrightDaysII)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
BLT
Bright light therapy delivered via glasses
OTHER
s-BLT
sham delivered with bright light therapy glasses to which a neutral density filter has been applied
Primary outcome measures
Change in Epworth sleepiness scale
Time frame: baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)
self report questionnaire assessing daytime drowsiness and tendency to fall asleep if inactive
Change in QIDS score
Time frame: baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)
self report assessment of depressive symptoms severity
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Travel across time zones in the past month
- 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
- 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
Where
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 9, 2026 · Source of record for eligibility and locations