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New treatment option for Obstructive Sleep Apnea
Official title Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness
ClinicalTrials.gov ID: NCT06698809
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.