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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright light therapy glasses
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 sleep apnea, CPAP, daytime sleepiness, bright light therapy

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veterans from the VA Pittsburgh Healthcare System (VAPHS)
  • Documented diagnosis of OSA
  • Currently on CPAP or BiPAP with documented adherence (defined as wearing CPAP/BiPAP for >4h/night on at least 75% of nights)
  • Excessive residual daytime sleepiness (Epworth score > 10)
  • Endorsing depressive symptoms (Quick Inventory of Depressive Symptomatology (Self-Report) [QIDS-SR] score>8)

Exclusion Criteria:

  • Shift work
  • Travel across time zones in the past month
  • Narcolepsy
  • Congestive heart failure (CHF)
  • Poorly controlled diabetes (HgA1c>7%)
  • Active substance use disorder
  • Dementia
  • Bipolar disorder

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

Retimer bright light therapy glasses

sham-Retimer bright light therapy glasses

Arm Description

active bright light therapy in the green/blue spectrum range

bright light therapy with light in the red spectrum (not active)

Outcomes

Primary Outcome Measures

Epworth Sleepiness Scale
Brief self report questionnaire used to quantify degree of daytime sleepiness. Minimum score is 0,maximum score is 24; values below 10 are considered normal
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Assesses impact of sleep related disturbances on daily functioning. It is a likert scale whose scaling of items is from zero to four.The potential range of scores for the total score is 5-20, with higher scores indicating worse functioning

Secondary Outcome Measures

Full Information

First Posted
March 2, 2020
Last Updated
May 18, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04299009
Brief Title
Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
Official Title
Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 13, 2022 (Actual)
Study Completion Date
September 13, 2022 (Actual)

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
Sleep apnea is one of the most common chronic condition among US military Veterans, causing sleepiness, reduced psychomotor vigilance and depression, which undermine daytime functioning and quality of life. 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. Residual daytime sleepiness (RDS) is associated with reduced occupational and family functioning and overall lower quality of life. Napping is a common behavior among individuals with OSA and RDS and has been linked to both benefits to and decline in health and functioning. Longer nap times may maintain, as opposed to decrease, sleepiness by promoting sleep inertia and can contribute to maintaining subclinical circadian alterations that result in higher night-tonight variability in sleep patterns. Preliminary studies in humans and animal models have shown persisting alterations of circadian rhythms in OSA patients, that fail to normalize with CPAP treatment. CPAP treatment, while effective at correcting respiratory events and night time blood oxygen saturation levels, does not necessarily re-align the circadian system. Current treatment options are limited to stimulants and modafinil, whose long-term safety profile, effectiveness and impact on functional recovery is largely unknown. 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. However, no study to date has tested the application of BLT to treat daytime symptoms associated with sleep apnea. The investigators' study will be the first to 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.
Detailed Description
Due to Covid 19 pandemic emergency measures, recruitment for clinical trials is currently on hold Background: Sleep apnea is one of the most common chronic condition among US military Veterans , it causes sleepiness, reduced psychomotor vigilance and depression, which undermine daytime functioning and quality of life . Persistent daytime symptoms of sleepiness and depression in individuals with OSA who are using Continuous Positive Airway Pressure (CPAP) are associated with adverse long term medical and functional outcomes . Current treatment options are limited to stimulants and modafinil, whose long-term safety profile, effectiveness and impact on functional recovery is largely unknown. The mechanisms for residual daytime symptoms in CPAP-treated sleep apnea are poorly understood and very little attention has been placed on interplay between sleep apnea and the circadian system. Notably, sleepiness, fatigue and depression, cardinal symptoms of OSA syndrome, are common manifestations of circadian misalignment. Circadian rhythms are synchronized to the environmental light or dark and to social activity cycles by zeitgebers (time givers) .Preliminary studies in humans and animal models have shown persisting alterations of circadian rhythms in OSA patients, that fail to normalize with CPAP treatment. CPAP treatment, while effective at correcting respiratory events and night time blood oxygen saturation levels, does not necessarily re-align the circadian system. 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. However, no study to date has tested the application of BLT to treat daytime symptoms associated with sleep apnea. The investigators' study will be the first to 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sleep apnea, CPAP, daytime sleepiness, bright light therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retimer bright light therapy glasses
Arm Type
Experimental
Arm Description
active bright light therapy in the green/blue spectrum range
Arm Title
sham-Retimer bright light therapy glasses
Arm Type
Sham Comparator
Arm Description
bright light therapy with light in the red spectrum (not active)
Intervention Type
Device
Intervention Name(s)
Bright light therapy glasses
Other Intervention Name(s)
BLT
Intervention Description
Bright light therapy delivered through glasses
Primary Outcome Measure Information:
Title
Epworth Sleepiness Scale
Description
Brief self report questionnaire used to quantify degree of daytime sleepiness. Minimum score is 0,maximum score is 24; values below 10 are considered normal
Time Frame
change from baseline to week 12
Title
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Description
Assesses impact of sleep related disturbances on daily functioning. It is a likert scale whose scaling of items is from zero to four.The potential range of scores for the total score is 5-20, with higher scores indicating worse functioning
Time Frame
change from baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans from the VA Pittsburgh Healthcare System (VAPHS) Documented diagnosis of OSA Currently on CPAP or BiPAP with documented adherence (defined as wearing CPAP/BiPAP for >4h/night on at least 75% of nights) Excessive residual daytime sleepiness (Epworth score > 10) Endorsing depressive symptoms (Quick Inventory of Depressive Symptomatology (Self-Report) [QIDS-SR] score>8) Exclusion Criteria: Shift work Travel across time zones in the past month Narcolepsy Congestive heart failure (CHF) Poorly controlled diabetes (HgA1c>7%) Active substance use disorder Dementia Bipolar disorder
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

12. IPD Sharing Statement

Plan to Share IPD
No

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

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