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

Must not have

Primary central sleep apnea, needing O2 therapy via nasal cannula

Decompensated congestive heart failure (CHF)

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)

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I often feel very sleepy during the day.

Select...

I have been diagnosed with obstructive sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have central sleep apnea and need oxygen therapy through my nose.

Select...

I do not have worsening heart failure that requires hospitalization.

Select...

I am on medication that makes my skin sensitive to certain light.

Select...

I am legally blind.

Select...

I have bipolar disorder and have not received treatment for it.

Select...

I have been diagnosed with narcolepsy.

Select...

My diabetes is not well-controlled (HgA1c over 8%).

Select...

I am currently using bright light therapy.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 (end of treatment 1), week 8 (end of wash out), week 12 (end of treatment 2) for reporting.