Taking people in United StatesNo phase

Red light therapy for leftover sleepiness in obstructive sleep apnea

Tests light applied through the scalp for sleepiness in people with obstructive sleep apnea.

Key facts

Who runs it: NYU Langone Health
Where: New York, United StatesSee the site
Trial code: NCT06698809
Registry title: Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness
Status: Recruiting
People taking part: 22 people, planned
Started: 12 Jan 2026
Planned end: 3 Oct 2026
Type of study: Interventional
Treatments tested: Active tPBM
Record updated: 14 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate to severe obstructive sleep apnea who are still sleepy during the day despite regular CPAP use. They will try a light-based brain treatment called tPBM.

Age: 18 Years to 75 Years
Sex: All sexes can join.
Disease stage: Moderate to severe obstructive sleep apnea (OSA), with daytime sleepiness: Epworth Sleepiness Score (ESS) of 8 or more, or excess daytime sleepiness on the Functional Outcome Sleep Questionnaire or by clinical complaint. Normal thinking and memory (TiCS score of 29 or more).
Earlier treatment: Must be on OSA treatment for at least 3 months. Must use CPAP at least 4 hours per night, five nights a week. No light-activated drugs (photodynamic therapy) within 14 days before joining.

Main reasons for not taking part

Chronic insomnia, circadian rhythm disorder, other sleep-related breathing disorders, or use of supplemental oxygen.
Night shift work in the past 6 months, or work as a commercial driver or construction worker.
Regular use of sedatives, stimulants, neuroleptic drugs, or methylphenidate for ADHD.
Brain diseases such as stroke, epilepsy, Parkinson's or Alzheimer's disease, or uncontrolled psychiatric disease.
Pregnancy or planning pregnancy, head implants, or being unable to have an MRI safely.

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

Cognitively normal (Telephone Interview for Cognitive Status (TiCS) ≥29))
Moderate - severe OSA
Currently on therapy for OSA and has received treatment for OSA for at least 3 months
Sustained compliance with continuous positive airway pressure (CPAP), which means using the machine at least 4 hours per night for five nights a week
Epworth Sleepiness Score (ESS) greater than or equal to 8 or excess daytime sleepiness as defined by the Functional Outcome Sleep Questionnaire or clinical complaint

Who cannot take part

Anticipated scheduled bariatric surgery within the next 3 months
Chronic regular (> 2 nights per week) use of any sedative, stimulant, neuroleptic drugs, or other medications limiting validity of cognitive tests. This includes regular use of alcohol or marijuana for sleep. Melatonin is ok
Chronic regular (> 2 nights per week) use of stimulant if unable to complete a washout prior to MRI
Prior diagnosis of a Central nervous system (CNS) disease, such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, epilepsy, a loss of consciousness > 24 hours, or traumatic brain injury as identified by the Cumulative Illness Rating Scale for Geriatrics (CIRS). Participants who are diagnosed with Mild cognitive impairment (MCI) or Alzheimer's disease based on neuropsychological testing will be excluded. Delirium in the last 12 months
Near-miss or prior automobile accident "due to sleepiness" within the past 12 months
Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment
Any type of implants in the head, whose functioning might be affected by tPBM (e.g., stent, clipped aneurysm, embolized arteriovenous malformation (AVM), implantable shunt - Hakim valve)
Documented diagnosis of circadian rhythm disorder
Other sleep-related breathing disorders (central sleep apnea, etc.) based on American Academy of Sleep Medicine (AASM) criteria
Diagnosis of uncontrolled psychiatric disease in the last six months, and/or history of schizophrenia or bipolar disorder. Controlled conditions will include major depressive disorder, panic disorder, schizoaffective disorder, generalized anxiety disorder, Obsessive-compulsive disorder (OCD), substance use disorders, and alcohol abuse/dependence. Personality disorders and neurodevelopmental disorders (e.g. autism, ADHD) are allowed if cognition is within normal limits
Presence of other critical comorbid conditions that would lead to inability to complete the study protocol (including follow-up for 2 years), or that would affect cognition (e.g. clinically relevant endocrine or hematological conditions)
Past intolerance or hypersensitivity to tPBM
Significant skin conditions (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) on the subject's scalp that are found in the area of the procedure sites
Failure to meet standard MRI safety requirements (e.g., claustrophobia, non-removable piercings, implanted medical devices, other non-removable metals) as determined by the MRI Safety Checklist
Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index (ISI)
Any current use of supplemental oxygen
Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 months
Taking methylphenidate for ADHD
Does not have a regular sleeping environment (i.e., sleeps in a different setting > 2 nights per week)
Currently pregnant or planning to become pregnant
Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots) or construction worker

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 75 years old?

Where in United States

NYU Langone HealthNew York, United StatesContact: Naomi GaggiTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

Participants with Moderate-to-Severe OSATreatment being tested
Participants will receive tPBM treatment and sham 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.
Treatment: Active tPBM