Bright Light Therapy for OSA (BrightDaysII)

VA Office of Research and Development

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Other: BLT; Other: s-BLT

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05917119

F4531-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

BLT

Experimental group

Description:

Bright light therapy delivered via glasses

Treatment:

Other: BLT

s-BLT

Sham Comparator group

Description:

Sham Bright light therapy

Treatment:

Other: s-BLT