Recruiting

Bright Light Therapy

Sponsor:

VA Office of Research and Development

Code:

NCT05917119

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Not accepted

Interventions

BLT

s-BLT

Study Details

Brief summary:

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.

Conditions

Obstructive Sleep Apnea

Study ID

NCT05917119

Start date

Oct 26, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BLT

Bright light therapy delivered via glasses

sham comparator: s-BLT

Sham Bright light therapy

Interventions

BLT

Bright light therapy delivered via glasses

s-BLT

sham delivered with bright light therapy glasses to which a neutral density filter has been applied

Primary outcome measure

  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Isabella Soreca, MD

(412) 688-6000Isabella.Soreca@va.gov

L. A Pisarov

(412) 360-2251Liubomir.Pisarov@va.gov

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contacts

Isabella Soreca, MD

412-688-6000Isabella.Soreca@va.gov

Principal Investigator:

Isabella Soreca, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

  • Obstructive sleep apnea
  • CPAP
  • Residual daytime sleepiness
  • Depressive symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-09.