Bright Light Therapy for OSA

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
VA Office of Research and Development
Study ID
NCT05917119
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
40 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • BLT — OTHER
    Bright light therapy delivered via glasses
  • s-BLT — OTHER
    sham delivered with bright light therapy glasses to which a neutral density filter has been applied

Study Details

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.

Key Dates

Start date
Oct 26, 2024
Status verified
Jan 2026
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: BLT
    Bright light therapy delivered via glasses
  • Sham Comparator: s-BLT
    Sham Bright light therapy

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburghPennsylvania15240
Isabella Soreca, MD
[email protected]
412-688-6000
Isabella Soreca, MD (PRINCIPAL_INVESTIGATOR)

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VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA· Pittsburgh, PA

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