Longitudinal Outcomes and Adherence of the Inspire System, EURO-STIM Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 21
- 主要终点
- Apnea Hypopnea Index (AHI)
研究概览
简要总结
The registry is to measure longitudinal outcomes and adherence of the Inspire System. The goal of the registry is to capture the life cycle of the patient's use of the Inspire System through routine clinical care visits. There are no required interventions or testing.
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
- 否
入选标准
- •Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:
- •Capable of giving informed consent, as required per institution
- •Willing to return for routine clinic visits as required for Inspire therapy management
排除标准
- •Any patient who meets any of the following criteria will not be eligible to participate in the registry:
- •Has a life expectancy of less than one year
- •Any reason the clinician deems patient is unfit for participation in the study
结局指标
主要结局
Apnea Hypopnea Index (AHI)
时间窗: Total AHI, supine and non-supine AHI, documented as events/hour of sleep will be collected at baseline, prior to implant, and at follow-up visits, if available, as determined by clinical standard of care.
The AHI, or number of apnea and hypopnea events per hour, is a measure of OSA severity.
Epworth Sleepiness Scale (ESS)
时间窗: ESS will be collected at baseline and follow-up visits, if available, as determined by clinical standard of care.
The ESS is a validated, self-report instrument that rates a subject's tendency to fall asleep in eight common daily situations13. The ESS has been validated primarily in OSA.
次要结局
- DISE VOTE Classification(DISE VOTE Score will be collected, if available, at baseline.)
- Functional Outcomes of Sleep Questionnaire (FOSQ-30)(FOSQ-30 will be collected at baseline and follow-up visits, if available and only if already collected as part of routine clinical care.)
- Patient Experience with Therapy (PET)(PET will be collected at follow-up visits after device activation, if available.)
- Maintenance of Wakefulness Test (MWT)(Sleep latency is recorded in minutes and may be collected from a maintenance of wakefulness test performed at baseline and follow-up visits after device activation, if available.)
- Therapy Use(Therapy use will be collected at follow-up visits after device activation, if available.)
- Adverse Events(The number of events (as well as the % of subjects in which the event occurred) will be reported at implant and at follow-up timepoints.)