Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
- 试验地点
- 62
- 主要终点
- Change in Apnea Hypopnea (AHI) from Baseline to 12-Months
研究概览
简要总结
Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis.
In addition, a sub-study will be conducted under this Registry at a limited number of Registry centers and will include a cohort of Registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.
详细描述
This registry is a multi-center, prospective, observational registry, conducted in the United States and Europe. Some data may be collected retrospectively in patients currently implanted (implanted prior to enrollment) through the 12-month follow-up time frame. The CE-marked and FDA-approved Inspire system will be used within its intended use, allowing for of use of any future approved system component models. This protocol does not include any additional stressful or invasive tests, which are not a part of standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 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 1 year
- •Any reason the clinician deems patient is unfit for participation in the study
结局指标
主要结局
Change in Apnea Hypopnea (AHI) from Baseline to 12-Months
时间窗: Baseline through 12 months
Apnea Hypopnea Index (AHI) is a measure of OSA severity. The AHI will be determined by the AHI score at the post-titration visit compared with the pre-implant baseline score.
Change in Epworth Sleepiness Scale (ESS) from Baseline to 12 Months
时间窗: Baseline through 12 months
The Epworth Sleepiness Scale (ESS) is a validated instruction that rates a subject's daytime sleepiness. ESS scores range from 0 to 24, with a lower score indicating less daytime sleepiness. An ESS score of 10 or less is equivalent to the normalized population. The ESS efficacy endpoint will be determined by the ESS score at the 12-month follow-up as compared to baseline.
次要结局
- Therapy Adherence(Through 12 months)
- Advance or Additional Titrations(Through 12 months)
- Patient Experience with Therapy (PET)(Through 12 months)
- Insomnia Severity Index (ISI)(Baseline through 12 months)
- Physical Assessment(Baseline through 12 months)
- Clinical Global Impression (CGI-I)(Baseline through 12 months)
- Device Data Collection(Through 12 months)