NCT05252156已完成不适用
An Open-label Randomized Controlled Trial Assessing the Efficacy of Two Levels of Intraoral Neuromuscular Electrical Stimulation for Moderate Obstructive Sleep Apnea: The ELMO Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 7
- 主要终点
- The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy
研究概览
简要总结
The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with moderate OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA (administered at two doses) versus no-therapy for six weeks. Up to 120 participants will be enrolled, in order to randomized n=62.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >=18 years;
- •Diagnosed with moderate OSA;
- •Smartphone or tablet capable of running the eXciteOSA app;
- •Fluent in written and spoken English.
排除标准
- •BMI >=35 kg/m2;
- •Implanted medical device;
- •Dental braces and/or intraoral metal jewelry;
- •Any condition impacting the tissue of the oral cavity, including but not limited to ulceration or periodontitis;
- •Symptomatic nasal pathology such as septal deviation, nasal polyposis, or chronic rhinosinusitis;
- •Tonsillar hypertrophy (tonsil size grade 3 or greater);
- •Clinically significant facial or oropharyngeal abnormalities such as class 2 malocclusion;
- •Prior oropharyngeal surgery for sleep-disordered breathing;
- •At-home use of a mandibular advancement device or PAP for sleep-disordered breathing within the previous four weeks;
- •Use of any overnight therapy that cannot be withdrawn during study enrollment;
- •Diagnosed with any sleep disorder other than OSA;
- •Chronic use of central nervous system depressants;
- •Driver in a sleepiness-related vehicular accident or near-miss within the two years prior to enrolment (self-report);
- •Employed as a commercial driver, pilot, or other occupation that may be impacted by hypersomnolence;
- •Considered by the PI to be at risk of an AE resulting from hypersomnolence;
- •Any periods of non-connectivity (wifi or cellular data) exceeding 48 hours planned to take place, or likely to take place, during enrollment;
- •Current or planned pregnancy;
- •Member of a vulnerable population, including but not limited to prisoners and those lacking consent capacity;
- •Clinically-significant burden of comorbidities (including history of myocardial infarction, cardiac arrhythmia, heart failure, history of stroke, or transient ischemic attack), and/or any other limitation or condition that may impact the patient's ability to complete the study protocol and use the device per the Instructions for Use (PI discretion);
- •Employee and/or residing household member who is an employee of a company that produces or distributes products designed to diagnose, treat, and/or monitor sleep or sleep-disordered breathing (including the Sponsor).
研究组 & 干预措施
Therapy Dose-A
Experimental
Neuromuscular electrical stimulation; two 20-minute sessions per day.
干预措施: eXciteOSA (Device)
Therapy Dose-B
Experimental
Neuromuscular electrical stimulation; one 30-minute session per day.
干预措施: eXciteOSA (Device)
No Therapy
No Intervention
Under the care of the referring physician, with no therapy applied
结局指标
主要结局
The difference in the delta-REI (baseline to follow-up) between therapy (Dose-A and Dose-B combined) and no therapy
时间窗: Six weeks
次要结局
未报告次要终点
研究者
研究点 (7)
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