Bright Light Therapy for OSA

Obstructive Sleep Apnea Clinical Trial

— BrightDaysII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917119
• Other study ID #: F4531-R
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: Isabella Soreca, MD
• Phone: (412) 688-6000
• Email: Isabella.Soreca[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• BLT
Bright light therapy delivered via glasses
• s-BLT
sham delivered with bright light therapy glasses to which a neutral density filter has been applied

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)