Bright Light Therapy for OSA

NCT05917119 | Recruiting

• 1 other identifier: F4531-R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

BLT

EXPERIMENTAL

Bright light therapy delivered via glasses

Other: BLT

s-BLT

SHAM COMPARATOR

Sham Bright light therapy

Other: s-BLT

Interventions

BLT OTHER

Bright light therapy delivered via glasses

Also known as: Bright light therapy-Active intervention

BLT

s-BLT OTHER

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

Also known as: sham-Bright light therapy

s-BLT

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Depression

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Isabella Soreca, MD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabella Soreca, MD

CONTACT

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

L. A Pisarov

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not told which arm is active versus sham
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: single blind crossover design with randomized condition order

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: October 26, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)