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Behavioural Intervention
Bright Light Therapy for Sleep Apnea (BrightDaysII Trial)
N/A
Recruiting
Led By Isabella Soreca, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Excessive residual daytime sleepiness (Epworth score > 10)
Documented diagnosis of OSA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)
Awards & highlights
BrightDaysII Trial Summary
This trial explores if bright light therapy (BLT) can reduce daytime symptoms in people with sleep apnea using CPAP, a device that helps them breathe. BLT is a non-drug treatment for sleep disturbances.
Who is the study for?
This trial is for individuals with obstructive sleep apnea (OSA) who still feel very sleepy during the day despite using CPAP machines regularly. They must have used their CPAP for at least 3 months, not have central sleep apnea or certain other health conditions, and cannot be on medications that affect light sensitivity.Check my eligibility
What is being tested?
The study tests Bright Light Therapy (BLT) to see if it helps reduce daytime sleepiness in OSA patients who use CPAP. Participants will try both real BLT and a fake version without knowing which is which, each for four weeks, to compare effects.See study design
What are the potential side effects?
Bright Light Therapy may cause eye strain or headaches in some people. Since it's non-pharmacological, there are fewer side effects compared to medication; however, those sensitive to light might experience discomfort.
BrightDaysII Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I often feel very sleepy during the day.
Select...
I have been diagnosed with obstructive sleep apnea.
BrightDaysII Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Epworth sleepiness scale
Change in QIDS score
BrightDaysII Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BLTExperimental Treatment1 Intervention
Bright light therapy delivered via glasses
Group II: s-BLTPlacebo Group1 Intervention
Sham Bright light therapy
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,224 Total Patients Enrolled
Isabella Soreca, MDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 Previous Clinical Trials
14 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used BLT for at least one month.I have central sleep apnea and need oxygen therapy through my nose.I do not have worsening heart failure that requires hospitalization.You are currently addicted to drugs or alcohol.I am on medication that makes my skin sensitive to certain light.I have bipolar disorder and am currently receiving treatment that keeps my condition stable.You have been using CPAP or BiPAP for at least 3 months, wearing it for more than 6 hours a night on most nights, and your sleep apnea is well controlled with an AHI of 10 or less when using the device.I have macular degeneration or had LASIK surgery within the last 3 months.You have a condition that causes memory loss and difficulty in thinking and problem-solving.You regularly take sleeping pills.You work at night or have irregular work hours.You have traveled to a different time zone in the past month.I am legally blind.I often feel very sleepy during the day.I have been on a stable dose of my alertness medication for at least one month.I have bipolar disorder and have not received treatment for it.I have been diagnosed with obstructive sleep apnea.I have been diagnosed with narcolepsy.My diabetes is not well-controlled (HgA1c over 8%).I am currently using bright light therapy.
Research Study Groups:
This trial has the following groups:- Group 1: BLT
- Group 2: s-BLT
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I enroll in this trial?
"To participate in this research, individuals should be 40 to 65 years old and have a diagnosis of obstructive sleep apnea. The total number of enrollees is limited to 60 patients."
Answered by AI
Are there any open enrollment opportunities for this experiment?
"Clinicialtrials.gov reveals that this medical trial, which was published on October 31st 2023 and last updated June 14th 2023, is not currently recruiting patients. Fortunately there are an abundance of other clinical trials in need of participants at the present moment."
Answered by AI
Does this medical research program accommodate individuals who are still of youthful age?
"This research study only permits those between the ages of 40 and 65 to participate. However, there are 44 studies that cater to minors (under 18) and 209 for senior citizens (above age 65)."
Answered by AI
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