NCT04932486已完成不适用
Randomised Controlled Trial of Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sunrise
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Apnea-hypopnea index (AHI)
研究概览
简要总结
The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the upper airway muscles in patients with obstructive sleep apnea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Obstructive apnea-hypopnea index > 15 events/hour
- •Patients who do not tolerate or do not accept positive airway pressure therapy
排除标准
- •Body mass index < 18.5 or > 32 kg/m2
- •Unable or incapable of providing informed written consent
- •Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
- •Significant co-morbidities making the patient unable or inappropriate to participate in the trial
研究组 & 干预措施
Transcutaneous electrical stimulation
Experimental
Participants will be asked to use the stimulator for 6 weeks at home. The study objectives will be evaluated after 6 weeks post-activation of the device.
干预措施: Transcutaneous electrical stimulation (Device)
结局指标
主要结局
Apnea-hypopnea index (AHI)
时间窗: 6 weeks
Change from baseline to 6 weeks in the apnea-hypopnea index (AHI)
次要结局
未报告次要终点
研究者
研究点 (1)
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