Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 929
- 试验地点
- 37
- 主要终点
- Apnea Hypopnea Index
研究概览
简要总结
The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of the hypoglossal nerve. Study objectives include demonstrating that the Inspire system improves key indices of sleep apnea in a pre-specified percentage of patients.
详细描述
The STAR trial is a multicenter, prospective trial that includes a randomized controlled therapy withdrawal study. The primary and secondary endpoint data were collected during an in-laboratory sleep study 12 months after the device implant and were compared against the baseline sleep studies. Following the 12-month visit, 46 consecutive responding subjects were randomized 1:1 to either a therapy maintenance group (ON group) or a therapy withdrawal group (OFF group). A subsequent sleep study of the two randomized groups was conducted and results were compared between the two groups. In addition, quality of life questionnaires were administered at baseline and at the 12-month visit to further assess the effectiveness of Inspire therapy.
The STAR trial was conducted at 15 clinical sites in the United States and 7 in Europe. Of the 126 implanted subjects in the STAR trial, 87 or 69% were implanted in the United States. The remaining 39 subjects or 31% were implanted in Europe.
The STAR trial subjects were evaluated prior to implant to ensure the following: 1) that their pre-implant AHI (as scored during an in-laboratory sleep study prior to implant) was between 20 and 50 events per hour, 2) that any AHI contribution from central or mixed sleep apnea was less than 25%, 3) that subjects did not have primarily lateral OSA (defined as limited sleep apnea when lying on their side), and 4) that the subjects did not have a complete concentric collapse at the level of the soft palate while observed during a drug-induced sleep endoscopy (DISE).
After successful pre-implant screening, the subjects were implanted with the Inspire system. The subjects were allowed to recover for 1 month following surgery, at which time a second in-laboratory sleep study was conducted without activating the Inspire device. The results of this 1-month sleep study were averaged with the results of the pre-implant sleep study, and the average is defined as the subject's baseline.
The Inspire device is programmable in order to optimize a subject's response to therapy. The initial device settings are programmed in an office setting. Additional adjustments are made during an overnight sleep study whereby real time review of the polysomnogram (PSG) is available to aid in device setting adjustments during the 2 and 6-month visit.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Likely suffer moderate-to-severe OSA based on history and physical
- •Have failed or have not tolerated CPAP treatment
- •Willing and capable of providing informed consent
- •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 sleep studies, including the evaluation procedures and filling out the questionnaires
排除标准
- •Body Mass Index limits
- •Surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat
- •Significant co-morbidities making the patient unable or inappropriate to participate in the trial
研究组 & 干预措施
Inspire Therapy
Inspire Upper Airway Stimulation System, is a permanent, implantable therapy device, which consists of three implantable components: IPG, stimulation lead, and a sensing lead. In additional the patient receives a remote to activate the therapy.
干预措施: Inspire Upper Airway Stimulation System (Device)
结局指标
主要结局
Apnea Hypopnea Index
时间窗: 12 months
Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at the 12-month follow-up.
Oxygen Desaturation Index
时间窗: 12 months
Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy ODI responder was defines as a subject who experienced at least a 25% reduction in ODI from baseline.
Safety
时间窗: 12 months
The primary safety objective of this pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.
次要结局
- Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months(Baseline and 12 months)
- AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study(12 Months)
- Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects(12 months)
- Change in FOSQ From Baseline to 12 Months(Baseline and 12 months)
- Percentage Sleep Time at SaO2 < 90%(12 months)