Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Active tPBM
DevicetPBM 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.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: Participants with Moderate-to-Severe OSAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percent Change in Cerebral Blood Flow
Measured via MRI imaging.
Time frame
Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes)Secondary outcomes
1
Change in Karolinska Sleepiness Scale (KSS) Score
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.
Time frame
Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes)2
Change in Psychomotor Vigilance Task (PVT) Score
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 milliseconds or failing to respond. The total score is calculated by subtracting the number of lapses and false starts from 100%. The result is a percentage that ranges from 100% for optimal performance to 0% for worst possible performance.
Time frame
Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes)3
Change in Controlled Oral Word Association Test (COWAT) Score
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.
Time frame
Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
American Academy of Sleep Medicine
Collaborator
Source ClinicalTrials.gov