Bright Light Therapy for OSA (BrightDaysII)

Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea

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 Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: BLT; Other: s-BLT

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabella Soreca, MD; Phone Number: (412) 688-6000; Email: Isabella.Soreca@va.gov
• Study Contact Backup: Name: L. A Pisarov; Phone Number: (412) 360-2251; Email: Liubomir.Pisarov@va.gov

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • Recruiting
      • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
      • Contact: Isabella Soreca, MD; Phone Number: 412-688-6000; Email: Isabella.Soreca@va.gov
      • Principal Investigator: Isabella Soreca, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLT; Bright light therapy delivered via glasses	Other: BLT; Bright light therapy delivered via glasses; Other Names: Bright light therapy-Active intervention
Sham Comparator: s-BLT; Sham Bright light therapy	Other: s-BLT; sham delivered with bright light therapy glasses to which a neutral density filter has been applied; Other Names: sham-Bright light therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Isabella Soreca, MD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; CPAP; Depressive symptoms; Residual daytime sleepiness
• Additional Relevant MeSH Terms: Nervous System Diseases; Behavioral Symptoms; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Behavior; Depression; Sleep Apnea, Obstructive
• Other Study ID Numbers: F4531-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No