Actively Recruiting
Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness
Led by NYU Langone Health · Updated on 2026-01-14
22
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
A
American Academy of Sleep Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Obstructive sleep apnea (OSA) is a sleep disorder that is commonly treated using positive airway pressure, yet 50% of patients still experience residual sleepiness after successful therapy. A potential neuromodulation strategy that can decrease residual sleepiness is transcranial photobiomodulation (tPBM). tPBM is a neuromodulatory treatment that uses red and/or near infrared light to penetrate the cortex and can alter both cerebral metabolism and blood flow. However, this potential has never been explored before directly in sleep disordered individuals. This project aims to explore the effect of tPBM on sleepiness and understand the potential neural mechanism of tPBM in OSA. The short-term goal of this project is to collect pilot data, which is the first of its kind, and suggest tPBM as a potential modulator of sleepiness in OSA.
CONDITIONS
Official Title
Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cognitively normal with Telephone Interview for Cognitive Status (TiCS) score of 9 or higher
- Diagnosed with moderate to severe obstructive sleep apnea
- Currently receiving therapy for obstructive sleep apnea for at least 3 months
- Consistent use of continuous positive airway pressure (CPAP) at least 4 hours per night for five nights each week
- Epworth Sleepiness Score (ESS) of 8 or higher or experiencing excess daytime sleepiness based on clinical complaint or Functional Outcome Sleep Questionnaire
You will not qualify if you...
- Diagnosed with chronic insomnia or sleep onset insomnia based on Insomnia Severity Index (ISI)
- Diagnosed with circadian rhythm disorder
- Current use of supplemental oxygen
- Presence of other sleep-related breathing disorders such as central sleep apnea
- Working night shifts regularly within the past 6 months
- Scheduled bariatric surgery within the next 3 months
- Regular use (more than 2 nights per week) of sedatives, stimulants, neuroleptic drugs, or other medications that affect cognitive test validity, including regular alcohol or marijuana use for sleep; melatonin is allowed
- Uncontrolled psychiatric disease in the last 6 months or history of schizophrenia or bipolar disorder; certain controlled psychiatric conditions allowed
- Taking methylphenidate for ADHD
- Other serious health conditions affecting cognition or ability to complete the study including 2-year follow-up
- Regular stimulant use (more than 2 nights per week) without ability to complete washout before MRI
- Irregular sleeping environment (sleeping in different settings more than 2 nights per week)
- Currently pregnant or planning pregnancy
- Prior diagnosis of central nervous system diseases such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, epilepsy, traumatic brain injury, or mild cognitive impairment
- Delirium in the last 12 months
- Near-miss or accident due to sleepiness in the last 12 months
- Employed as commercial driver or construction worker during the study
- Past intolerance or hypersensitivity to tPBM
- Significant skin conditions or scalp issues at treatment sites
- Use of light-activated drugs within 14 days prior to enrollment
- Presence of head implants affected by tPBM
- Failure to meet MRI safety requirements such as claustrophobia, non-removable piercings, implanted devices, or metal presence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
N
Naomi Gaggi
CONTACT
J
Jennifer Bernal
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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