BrightDaysII: Bright Light Therapy for OSA

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT05917119

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Other: BLT Other: s-BLT	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

single blind crossover design with randomized condition ordersingle blind crossover design with randomized condition order

Masking:

Single (Participant)

Masking Description:

Participants are not told which arm is active versus sham

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 31, 2023

Anticipated Primary Completion Date :

May 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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