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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
RECRUITING
Pittsburgh
Contact Information
Primary
Isabella Soreca, MD
Isabella.Soreca@va.gov
(412) 688-6000
Backup
L. A Pisarov
Liubomir.Pisarov@va.gov
(412) 360-2251
Time Frame
Start Date: 2024-10-26
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
Experimental: BLT
Bright light therapy delivered via glasses
Sham_comparator: s-BLT
Sham Bright light therapy
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov