Bright Light Therapy for OSA

NCT ID: NCT05917119

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-26
• Study Completion Date: 2027-12-31

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.

Detailed 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BLT

Bright light therapy delivered via glasses

Group Type: EXPERIMENTAL

BLT

Intervention Type: OTHER

Bright light therapy delivered via glasses

s-BLT

Sham Bright light therapy

Group Type: SHAM_COMPARATOR

s-BLT

Intervention Type: OTHER

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

Interventions

BLT

Bright light therapy delivered via glasses

Intervention Type: OTHER

s-BLT

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

Intervention Type: OTHER

Other Intervention Names

Bright light therapy-Active intervention; sham-Bright light therapy

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabella Soreca, MD

Role: PRINCIPAL_INVESTIGATOR

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Isabella Soreca, MD

Role: CONTACT

Isabella.Soreca@va.gov

(412) 688-6000

L. A Pisarov

Role: CONTACT

Liubomir.Pisarov@va.gov

(412) 360-2251

Facility Contacts

Isabella Soreca, MD

Role: primary

Isabella.Soreca@va.gov

412-688-6000

Other Identifiers

F4531-R

Identifier Type: -

Identifier Source: org_study_id