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临床试验/NCT03980158
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

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

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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