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Bright Light Therapy for OSA

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether bright light therapy glasses help people with obstructive sleep apnea (OSA) who still feel sleepy during the day despite using a breathing machine. OSA causes breathing to stop and start during sleep. Each person will try real light treatment for 4 weeks and a sham (comparison) treatment for 4 weeks, in an order chosen by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a documented diagnosis of OSA.
  • Have used CPAP or BiPAP, machines that help you breathe during sleep, for at least 3 months.
  • Have records showing machine use for more than 6 hours a night on at least 75% of nights.
  • Have sleep apnea controlled with treatment: 10 or fewer pauses or drops in breathing per hour while using CPAP.
  • Still have strong daytime sleepiness, with a score above 10 on the Epworth sleepiness survey.
  • If taking medicine to stay alert, have taken the same dose for at least 1 month and keep that dose during the study.
  • If prescribed bright light therapy, have stopped using it at least 1 month before joining.

Who can't join

  • Do shift work or have traveled across time zones in the past month.
  • Have narcolepsy, a condition that causes strong daytime sleepiness, or regularly take sleep medicines.
  • Have worsening heart failure, or primary central sleep apnea (when the brain does not signal breathing) needing oxygen through nose tubes.
  • Have poorly controlled diabetes, with an A1c blood sugar test above 8%.
  • Have a current substance use disorder or dementia, which affects memory and thinking.
  • Have untreated bipolar disorder, which causes major mood changes. People whose condition is treated and stable may be considered.
  • Have macular degeneration, an eye disease affecting central vision; had LASIK eye surgery within 3 months; or are legally blind.
  • Take medicine that makes you sensitive to blue-green light, or are already using bright light therapy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

PA