Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness

Not Applicable

Not yet recruiting

• Conditions: Obstructive Sleep Apnea; Sleepiness

• Registration Number: NCT06698809
• Lead Sponsor: NYU Langone Health

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 an...

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Study Start: 2024-12-01
• Primary Completion: 2025-10-25
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Cognitively normal (Telephone Interview for Cognitive Status (TiCS) ≥29))
• Moderate - severe OSA defined clinical testing in past 12 months or confirmed by repeat test
• Currently on therapy for OSA and has received treatment for OSA for at least 12 months. The standard for CPAP treatment includes AHI levels that are below a defined threshold, please see above, (i.e., below and absolute number or below a percentage from pre-treated AHI).
• 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 10.

Read More

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, 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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent Change in Cerebral Blood Flow	Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes)	Measured via MRI imaging.

Secondary Outcome Measures

Name	Time	Method
Change in Karolinska Sleepiness Scale (KSS) Score	Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes)	The KSS is a 1-item assessment of sleepiness in the 5 minutes prior to administration of the questionnaire. Participants rank their sleepiness on a scale from 1 (extremely alert) to 9 (very sleepy). The total score is the item ranking and ranges from 1-9; higher scores indicate greater sleepiness.
Change in Psychomotor Vigilance Task (PVT) Score	Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes)	The psychomotor vigilance task (PVT) is a computer-based test that measures how consistently someone responds to visual or auditory stimuli over 10 minutes. The participant presses a button in response to a digital signal on a computer screen. The test measures reaction time and the number of lapses, which are defined as response times longer than 500 millis...
Change in Controlled Oral Word Association Test (COWAT) Score	Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes)	The COWAT is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe. The total score is the number of correct words named by the participant.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States