Alesis OSA-1 Double-Blinded Randomized Study of Obstructive Sleep Apnea Treatment Using A Patented Noncoherent Medical Light
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- AHI Events
研究概览
简要总结
The goal of randomized clinical trial is to determine if the Alesis OSA-1 low laser light therapy device can reduce apnea-hypopnea index scores and treat sleep apnea in adult participants over the age of 18 who are diagnosed with obstructive sleep apnea (OSA). The main questions it aims to answer are]:
• Does the use of the Alesis OSA-1 device reduce the number of AHI events after six treatments of 12 minutes each, 2x per week x 3 weeks, in adult OSA patients?
Researchers will compare results of 35 control group participants who will not receive treatment to a treatment group who will receive six, 12 minute, non-invasive low laser light therapy (LLLT) treatments, two per week for 3 weeks, to see if there is a reduction in the number of AHI events and size of redundant and soft tissues in adult OSA patients.
Participants will:
- Visit the clinic for assessment and instructions on using the at home sleep study system, WatchPat, and obtain baseline information
- Use the WatchPat system to record AHI events pre- and post-treatment.
- 10 randomly selected participants will receive a pre-study pulmonary functions test (PFT) and repeated post-treatment.
- 5 randomly selected participant will receive a pre-study MRI of the head/neck and repeated post treatment.
- For the treatments, the participant lie on a treatment table under a LLLT device for 12 minutes, two times per week, x 3 weeks.
- Be offered the treatment series at the conclusion of the study if they were selected for the control group.
详细描述
PURPOSE To evaluate the efficacy of the non-invasive Alesis Low-Level Light Therapy (LLLT) medical device in treating obstructive sleep apnea (OSA) by assessing changes in upper airway fat deposits via. Magnetic resonance imaging (MRI) after treatments; Apnea-Hypopnea Index (AHI) events; and STOP-BANG scores pre- and post-treatment; determining its potential to reduce fat and improve airway patency in adults with mild to severe OSA.
OBJECTIVES
- To evaluate changes in the size of the tongue and soft tissue structures in obese subjects diagnosed with obstructive sleep apnea (OSA).
- To assess improvements in the Apnea-Hypopnea Index (AHI) following treatment with the Alesis Airway LLT Modification Device.
STUDY DESIGN
- Type: Prospective, repeated measures, double blind, randomized controlled trial
- Participants: N = 70 for original study, N = 5-10 MRI subset, N = 35 for ethical consideration offering (See Ethics considerations)
- Sampling Method: Volunteer convenience sample
- Duration: 6 months
- Special subset A: A subset of 3-10 participants will undergo a MRI evaluation to measure submental and tongue fat size, pre- and post-treatment (Reference: Schwab, et al. 2014, Tongue fat and OSA relationship)
- Repeated Measures: Post-Treatment HST week 2, week 3
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suspicion of OSA, known diagnosis of OSA, STOP BANG score of 3 or greater, BMI >/= 25
排除标准
- •Beard or facial hair, diagnosis of central sleep apnea, inability to hold mouth open 12 minutes, Age less than 18 years old, • Severe comorbid conditions that may affect treatment or inability to lie flat or sit for 20 minutes (e.g., severe cardiac disease, uncontrolled diabetes); Contraindications to MRI (e.g., non-MRI-compatible pacemakers); History of recent upper airway surgery; Active cancer or cancer treatment completion within 1 year; Contraindications to LLLT such as systemic lupus erythematosis (SLE); Photosensitivity; Pregnancy; Renal disease; Facial fillers within 3 months; Diabetes medications (light sensitivity) Sulfonylurea medications, Metformin, Sitagliptin; Liver disease; Autoimmune disorders; Albinism; Antibiotic therapy-Tetracyclines, Fluoroquinolones (ciprofloxacin, ofloxacin, levofloxacin); Sulfonamides, Tricyclic antidepressants.
结局指标
主要结局
AHI Events
时间窗: From enrollment until the end of treatment at 3 weeks.
Apnea-hypoapnea events will be documented on the at home OSA sleep study (WatchPat) device. The number of AHI events occurring pre and post treatment will be evaulated for improvement;
次要结局
- Fat and tissue volume reduction(From enrollment to the end of treatment at 3 weeks)
- Pulmonary Functions Volumes(From enrollment to end of treatment in 3 weeks)