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Neuromodulation

Transcranial Photobiomodulation for Obstructive Sleep Apnea (STIL TIRED Trial)

N/A

Waitlist Available

Led By Naomi Gaggi

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently on therapy for OSA and has received treatment for OSA for at least 12 months with AHI levels below a defined threshold

Moderate - severe OSA defined by clinical testing in the past 12 months or confirmed by repeat test

Must not have

Documented diagnosis of chronic insomnia or sleep onset insomnia

Current use of supplemental oxygen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-active tpbm treatment, post-active tpbm treatment (day 1, approx. 11-12 minutes)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study a new treatment called transcranial photobiomodulation (tPBM) for patients with obstructive sleep apnea (OSA) who still experience sleepiness even

Who is the study for?

This trial is for individuals with Obstructive Sleep Apnea (OSA) who still feel very sleepy during the day even after using standard treatments. Participants should be those looking to try a new therapy involving light to potentially improve wakefulness.

What is being tested?

The study is testing transcranial photobiomodulation (tPBM), which uses specific types of light on the brain, as a treatment to reduce sleepiness in people with OSA. It's an early-stage trial aiming to gather initial data on tPBM's effectiveness and how it works.

What are the potential side effects?

Since this is a pilot study exploring tPBM, detailed side effects are not yet fully known. However, potential risks may include discomfort at the site of application or temporary visual disturbances due to exposure to bright light.

Eligibility Criteria

Inclusion Criteria

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

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I have been treated for sleep apnea for over a year and my condition is under control.

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I have been diagnosed with moderate to severe sleep apnea in the last year.

Exclusion Criteria

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

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I have been diagnosed with chronic insomnia or trouble falling asleep.

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I use supplemental oxygen.

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I have not had uncontrolled psychiatric issues or a history of schizophrenia or bipolar disorder in the last six months.

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I am scheduled for weight loss surgery in the next 3 months.

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I am currently taking medication for ADHD.

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I have been diagnosed with a brain or spinal cord disease.

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I work as a commercial driver or construction worker.

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I have been diagnosed with a disorder affecting my sleep/wake cycle.

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I have serious skin issues on my scalp.

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I have not used any light-activated drugs in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-active tpbm treatment, post-active tpbm treatment (day 1, approx. 11-12 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-active tpbm treatment, post-active tpbm treatment (day 1, approx. 11-12 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-active tpbm treatment, post-active tpbm treatment (day 1, approx. 11-12 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent Change in Cerebral Blood Flow

Secondary study objectives

Change in Controlled Oral Word Association Test (COWAT) Score

Change in Karolinska Sleepiness Scale (KSS) Score

Change in Psychomotor Vigilance Task (PVT) Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with Moderate-to-Severe OSAExperimental Treatment1 Intervention

Participants will receive tPBM treatment for approximately 12 minutes and complete assessments. Participants have the choice to participate in an optional follow-up 1 week post-initial visit, in which they will receive tPBM treatment for approximately 11-12 minutes and complete assessments at a different time of day.

0 / 12Eligibility criteria met