Bright Light Therapy for OSA

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: BLT; Other: s-BLT

• Registration Number: NCT05917119
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Study Start: 2024-10-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27
• Primary Completion: 2027-05-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BLT	BLT	Bright light therapy delivered via glasses
s-BLT	s-BLT	Sham Bright light therapy

Primary Outcome Measures

Name	Time	Method
Change in QIDS score	baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)	self report assessment of depressive symptoms severity
Change in Epworth sleepiness scale	baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)	self report questionnaire assessing daytime drowsiness and tendency to fall asleep if inactive

Trial Locations

Locations (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA; 🇺🇸 Pittsburgh, Pennsylvania, United States