Transcranial red/near-infrared light therapy for lingering sleepiness in obstructive sleep apnea

Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness (STILL TIRED)

This trial will test whether gentle red/near-infrared light to the head (tPBM) can reduce ongoing daytime sleepiness in people with moderate-to-severe obstructive sleep apnea who use CPAP.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: NYU Langone Health (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06698809 on ClinicalTrials.gov

What this trial studies

This is a pilot interventional study testing transcranial photobiomodulation (tPBM), which uses red and near-infrared light applied to the scalp, as a potential way to reduce residual sleepiness in treated OSA patients. Participants will be adults with moderate-to-severe OSA who have been using CPAP regularly and continue to report daytime sleepiness. The study will collect short-term clinical outcome measures of sleepiness using standard questionnaires and will gather preliminary neural data to explore potential mechanisms. The primary aim is to generate first-of-its-kind pilot data to inform larger trials.

Who should consider this trial

Good fit: Adults with moderate-to-severe OSA who have used CPAP regularly for at least three months, remain sleepy (ESS ≥8), and are cognitively normal are the ideal candidates.

Not a fit: People with chronic insomnia, circadian rhythm disorders, central sleep apnea, current supplemental oxygen use, recent night-shift work, or who are not compliant with CPAP are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, tPBM could provide a noninvasive option to reduce residual daytime sleepiness in OSA patients who remain sleepy despite effective CPAP therapy.

How similar studies have performed: tPBM has shown effects on cerebral blood flow and metabolism in other populations, but applying tPBM to reduce sleepiness in OSA is novel and has not been previously tested.

Eligibility criteria

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.

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Naomi Gaggi — NYU Langone Health
• Study coordinator: Naomi Gaggi

Conditions: Obstructive Sleep Apnea, Sleepiness, Transcranial Photobiomodulation