Recruiting

tPBM

Sponsor:

NYU Langone Health

Code:

NCT06698809

Conditions

Obstructive Sleep Apnea

Sleepiness

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Active tPBM

Study Details

Brief summary:

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

Obstructive Sleep Apnea

Sleepiness

Study ID

NCT06698809

Start date

Jan 12, 2026

Status verified date

Jan, 2026

Completion date

Oct 3, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with Moderate-to-Severe OSA

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.

Interventions

Active 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. Subjects will receive treatment for approximately 12 minutes per treatment and sham.

Primary outcome measure

  • Percent Change in Cerebral Blood Flow [ Time Frame: Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes) ]

Central Contacts and Locations

Central contacts

Naomi Gaggi

(646) 754-2238Naomi.Gaggi@nyulangone.org

Jennifer Bernal

(646) 754-2238Jennifer.Bernal@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Keywords

  • Transcranial Photobiomodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-01-14.