Obstructive Sleep Apnea and tPBM Study
This study is exploring a new treatment called transcranial photobiomodulation (tPBM) for people with obstructive sleep apnea (OSA) who still feel sleepy even after using their regular OSA therapy. tPBM uses red or near-infrared light to affect the brain. Researchers want to see if tPBM can reduce sleepiness and how it changes brain activity and blood flow. You might be able to join if you are 18-75 years old, have moderate to severe OSA, have been on OSA therapy for at least 3 months, and consistently use your CPAP machine. The study aims to enroll 22 participants. The main goal is to measure the change in blood flow in the brain right after receiving tPBM treatment.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 22 participants.
- What's involved
- Participants will receive tPBM treatment for about 12 minutes per session. The trial record does not specify the number of visits or the total duration of participation.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures changes in cerebral blood flow right after treatment on Day 1. Longer-term follow-up is not specified.
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NCT06698809
Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness
Recruiting
NAAges 18–75InterventionalTreatmentNYU Langone HealthInvestigator-initiated
~22 participants
Updated 2026-01-14 on ClinicalTrials.gov
What's tested:Active tPBM
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Change in Cerebral Blood Flow
Measured over Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes)
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Naomi Gaggi · PRINCIPAL_INVESTIGATOR · NYU Langone Health
- Ricardo Osario · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index (ISI)
Documented diagnosis of circadian rhythm disorder
Any current use of supplemental oxygen
Other sleep-related breathing disorders (central sleep apnea, etc.) based on American Academy of Sleep Medicine (AASM) criteria
Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 months
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.
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.
Taking methylphenidate for ADHD.
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).
Chronic regular (\> 2 nights per week) use of stimulant if unable to complete a washout prior to MRI.
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.
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.
Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots) or construction worker.
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.
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).
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.
What this trial measures
- Percent Change in Cerebral Blood FlowPre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes)
Measured via MRI imaging.