Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study: CE Certificate Number 562872
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Number of Reported SAEs / Procedure & Device Related AEs
研究概览
简要总结
The purpose of this study is to obtain additional safety and efficacy data on the use of Inspire® therapy for the treatment of subjects with moderate to severe Obstructive Sleep Apnea.
详细描述
This is a multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. Each subject will serve as their own control.
The study will collect pre-operative two-night home sleep testing, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected. Therapy usage and device adjustment data, as well as a subject satisfaction with therapy survey, will be collected for additional analysis.
Post-implant, procedure- and device-related events, QoL questionnaires, therapy usage and device adjustment data will be collected. Sleep study data will collected during the 2-month visit and, if conducted, a 3-month visit using a single night in-lab titration PSGs At 6 and 12 months post-implant, 2-night home sleep testing will be completed. Safety data will be collected throughout the study. Subjects will be exited from the study following the 12-month visits.
The subject population will consist of otherwise healthy men and women that are at least 21 years old and have: 1) Provided written informed consent to participate, 2) Indicated a willingness to comply with study requirements for the specified follow-up duration, 3) Met all inclusion and exclusion criteria of this protocol.
Up to 60 subjects will be implanted at up to 5 sites in Germany.
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
- •Likely suffer moderate-to-severe OSA based on history and physical, or have an established diagnosis of OSA (≥ 15 AHI<65) based on a prior sleep test
- •Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer 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
- •Contraindications
- •Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
- •Have any condition or procedure that has compromised neurological control of the upper airway
- •Unable or do not have the necessary assistance to operate the patient programmer
- •Pregnant or plan to become pregnant
- •Require magnetic resonance imaging (MRI)
- •Have an implantable device that may be susceptible to unintended interaction with the Inspire system.
- •Additional exclusions for study purposes only:
- •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
Number of Reported SAEs / Procedure & Device Related AEs
时间窗: 12 months post-implant
Safety of the therapy will be assessed via the description of all reported SAEs and all procedure- or device-related AEs. Adverse events will be summarized by seriousness, severity, relatedness to the device and/or procedure and temporal relationship to the procedure. No formal statistical hypotheses will be tested. Only device- or procedure-related AEs will be collected in this post-market study.
次要结局
- Change from Baseline OSA at 12 Months(12 months post-implant)