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Bright Light Therapy for OSA (BrightDaysII)

Primary Purpose

Obstructive Sleep Apnea

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BLT
s-BLT
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, CPAP, Residual daytime sleepiness, Depressive symptoms

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

BLT

s-BLT

Arm Description

Bright light therapy delivered via glasses

Sham Bright light therapy

Outcomes

Primary Outcome Measures

Change in Epworth sleepiness scale
self report questionnaire assessing daytime drowsiness and tendency to fall asleep if inactive
Change in QIDS score
self report assessment of depressive symptoms severity

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
June 14, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05917119
Brief Title
Bright Light Therapy for OSA
Acronym
BrightDaysII
Official Title
Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
May 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, CPAP, Residual daytime sleepiness, Depressive symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
single blind crossover design with randomized condition order
Masking
Participant
Masking Description
Participants are not told which arm is active versus sham
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BLT
Arm Type
Experimental
Arm Description
Bright light therapy delivered via glasses
Arm Title
s-BLT
Arm Type
Sham Comparator
Arm Description
Sham Bright light therapy
Intervention Type
Other
Intervention Name(s)
BLT
Other Intervention Name(s)
Bright light therapy-Active intervention
Intervention Description
Bright light therapy delivered via glasses
Intervention Type
Other
Intervention Name(s)
s-BLT
Other Intervention Name(s)
sham-Bright light therapy
Intervention Description
sham delivered with bright light therapy glasses to which a neutral density filter has been applied
Primary Outcome Measure Information:
Title
Change in Epworth sleepiness scale
Description
self report questionnaire assessing daytime drowsiness and tendency to fall asleep if inactive
Time Frame
baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)
Title
Change in QIDS score
Description
self report assessment of depressive symptoms severity
Time Frame
baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabella Soreca, MD
Phone
(412) 688-6000
Email
Isabella.Soreca@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
L. A Pisarov
Phone
(412) 360-2251
Email
Liubomir.Pisarov@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella Soreca, MD
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabella Soreca, MD
Phone
412-688-6000
Email
Isabella.Soreca@va.gov
First Name & Middle Initial & Last Name & Degree
Isabella Soreca, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Bright Light Therapy for OSA

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