Inspire® Upper Airway Stimulation System: Randomized Control Trial / European Post-Market Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 7
- 主要终点
- Change from Baseline OSA at 3 Months
研究概览
简要总结
The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper Airway System (UAS) in a commercial setting. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA) using a randomized controlled trial design.
详细描述
This study is a prospective, multi-center, randomized controlled study with a delayed start arm, conducted under a common implant protocol.
Up to 40 study subjects will be implanted at up to six centers in Europe. Subjects will be evaluated at baseline, implant, post-op (randomized) and 1-, 2-, 3,- 4- and 6-months post-implant.
Baseline data will include collection of demographics and medical history, completion of a physical exam, Functional Tongue Exam (FTE), and subject quality of life (QoL) questionnaires (Functional Outcomes of Sleep Questionnaire (FOSQ) and Epworth Sleepiness Scale (ESS)). Adverse event data will be collected from the time of baseline testing through the 6-month study follow-up.
Implant eligibility assessments will include home sleep testing (HST), a surgical consultation and a drug induced sedated endoscopy (DISE) to determine if the subject is a qualified candidate for implant.
Subjects meeting all baseline and pre-screening requirements will be implanted with the Inspire system. Intra- and post- operative procedure data will be collected. Subjects will be seen for a post-operative check one week after implant. During this visit, subjects will be randomized 1:1 to the ACTIVE group or the DELAY group. However, the Inspire system will not be activated (turned "on") during the first month post-implant to allow for post-surgical healing.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet the requirements per current CE Mark labeling
- •Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote to activate the stimulation
- •Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
- •Willing and capable of providing informed consent
排除标准
- •Do not meet any contraindications per current CE Mark labeling
- •Body Mass Index (BMI) of > 35
- •Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
- •Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
- •Has a terminal illness with life expectancy < 12 months
- •Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
- •Any other reason the investigator deems subject is unfit for participation in the study
结局指标
主要结局
Change from Baseline OSA at 3 Months
时间窗: 3 months post-implant
The percent of apnea hypopnea index (AHI) reduction will be used as a primary endpoint to quantify the effects of the Inspire therapy on OSA between the 'Active' therapy (ACTIVE) and 'Delayed Start' therapy (DELAY). The percent of AHI reduction is the percent change between baseline AHI at the pre-implant sleep study and AHI at the 3-month post-implant sleep study.
次要结局
- Number of Reported SAEs / Procedure & Device Related AEs(6 months post-implant)
- Change from Baseline Quality of Life Questionnaires (QoL)(6 months post-implant)
- Change from Baseline OSA at 6 Months(6 months post-implant)
- Change from Baseline Breathing Indices at 6 Months(6 months post-implant)