Clinical trial NCT05917119: Bright Light Therapy for OSA
Official title: Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
CPAP
Residual daytime sleepiness
Depressive symptoms
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: single blind crossover design with randomized condition order
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Epworth sleepiness scale
timeFrame: baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)
measure: Change in QIDS score
timeFrame: baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Isabella Soreca, MD
role: PRINCIPAL_INVESTIGATOR
References: