NCT03980158已完成不适用
Change in Tongue Strength and Fatigue After Implantation of Upper Airway Stimulation System
Technical University of Munich1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2018年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Tongue protrusion strength
研究概览
简要总结
Upper airway stimulation (UAS) is an effective surgical alternative for patients with obstructive sleep apnea (OSA) who fail continuous positive airway pressure (CPAP) therapy. This stimulation could lead to alterations in tongue strength and fatigability which could alter treatment outcome. The aim of the study is to investigate if UAS alters tongue strength and fatigability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years old or older
- •upper airway stimulation group: Upper airway stimulation system implanted at least 4 weeks ago
- •OSA group: OSA confirmed by 18-channel inpatient overnight polysomnography (PSG)
- •test group: No medical history for OSA and Epworth Sleepiness Scale (ESS) below 11
排除标准
- •history of a neuromuscular disorder
- •previous tongue surgery
结局指标
主要结局
Tongue protrusion strength
时间窗: Up to 60 months after implanation
Tongue protrusion strength (peak pressure in kPa)
Tongue fatigability
时间窗: Up to 60 months after implanation
Time to task failure during 50% of peak pressure contraction in seconds
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effect of Upper Airway Stimulation in Patients With Obstructive Sleep ApneaObstructive Sleep ApneaNCT03760328Technical University of Munich100
已完成
不适用
Tongue Advancement for Obstructive Sleep ApneaSleep Apnea, ObstructiveNCT00490984Aspire Medical60
已完成
不适用
Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation TherapyObstructive Sleep ApneaSleep-Disordered BreathingNCT06154577Cantonal Hosptal, Baselland65
Unknown
不适用
Clinical Study of Customized Adjustable Oral in Treatment of Patients With Obstructive Sleep Apnea SyndromeObstructive Sleep Apnea SyndromeNCT03729895Affiliated Hospital to Academy of Military Medical Sciences24
Unknown
1 期
Upper Airway Toning for Improve the Compliance of CPAPSleep Apnea, ObstructiveNCT01936038Fisiolistic110