Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness (STILL TIRED)
概览
- 阶段
- 不适用
- 干预措施
- Active tPBM
- 疾病 / 适应症
- Obstructive Sleep Apnea
- 发起方
- NYU Langone Health
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Percent Change in Cerebral Blood Flow
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
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.
研究者
入排标准
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Active tPBM
结局指标
主要结局
Percent Change in Cerebral Blood Flow
时间窗: Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes)
Measured via MRI imaging.
次要结局
- Change in Karolinska Sleepiness Scale (KSS) Score(Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes))
- Change in Psychomotor Vigilance Task (PVT) Score(Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes))
- Change in Controlled Oral Word Association Test (COWAT) Score(Pre-Active tPBM Treatment, Post-Active tPBM Treatment (Day 1, approx. 11-12 minutes))