Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- Comparison of Apnea-Hypopnea Index (AHI), between the two randomization arms
研究概览
简要总结
Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two randomization arms, at 6 months post-activation
详细描述
This study is a prospective, randomized, non-blinded, multi-center study of therapy optimization related to the Inspire UAS System (implanted in a commercial setting under current labeling).
Comparison of outcomes between two (2) groups of patients (both implanted with the Inspire UAS system) who undergo different post-implant care algorithms throughout follow-up, in order to determine whether home sleep monitoring may be used as a surrogate for an in-lab PSG titration in a sub-set of patients.
Subjects who have been identified as candidates for Inspire therapy (implant of the Inspire UAS system), according to commercial labeling, will be recruited to participate in the study.
A maximum of 100 subjects will be enrolled at up to 5 clinical centers. A total of 60 subjects will be randomized (1:1) to one of two study arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Patient is ≥ 22 years of age;
- •Patient has been diagnosed with moderate to severe OSA, with a baseline (pre-implant) AHI ≥ 15 based on a qualified sleep study;
- •Patient has been implanted with the Inspire UAS System but not yet activated, or has been scheduled for implant of the Inspire UAS System;
- •Patient currently owns a SmartPhone and is willing and able to install and use SmartPhone apps (at no cost to patient);
- •Patient is willing to utilize study equipment at home including Home Sleep Test (HST) equipment, pulse oximetry equipment, and sleep tracking equipment in accordance with the study protocol;
- •Patient is willing and able to return for all follow-up study visits;
- •Patient is willing to be randomized and adhere to randomization allocation;
- •Patient is willing to and capable of providing informed consent.
排除标准
- •Patient has central + mixed apneas more than > 25% of the total AHI;
- •Patient currently uses adjunctive sleep therapy (eg. CPAP, oral appliance, positional therapy) and will not discontinue use of adjunctive therapy upon implant of the Inspire UAS System;
- •Patient is pregnant or plans to become pregnant;
- •Patient has a terminal illness with life expectancy < 12 months;
- •Any other reason the investigator deems that the patient is unfit for participation in the study.
研究组 & 干预措施
Control
Subjects in this group will be implanted with the Inspire UAS system and will undergo a standard in-lab PSG titration study at approximately 3 months post-activation and a 2-night HST at approximately 6 months post-activation
Home Monitoring
Subjects who have undergone implant of the Inspire UAS System and are randomized to this group will undergo a 2-night HST at 3 months post-activation. Depending on the results of the 2-night HST, the subject will either (a) undergo a PSG titration at 5 months post-activation and a 2-night HST at 6 months post-activation OR (b) undergo only a 2-night HST at approximately 6 months post-activation
干预措施: Home Sleep Testing (Diagnostic Test)
结局指标
主要结局
Comparison of Apnea-Hypopnea Index (AHI), between the two randomization arms
时间窗: 6 months post-activation
The AHI endpoint will be determined by performing three equivalency tests for the following: Absolute AHI and, change in AHI. All comparisons will be done on the treatment AHI at 6 months between the control group and the home monitoring group. The objective is to demonstrate the equivalence in AHI, change in AHI, and response rate between the two groups.
次要结局
- Comparison of Epworth Sleepiness Scale (ESS), between the two randomization arms(6 months post-activation)
- Comparison of Oxygen Desaturation Index (ODI), between the two randomization arms(6 months post-activation)
- Comparison of Therapy Usage (hours per week), between the two randomization arms(6 months post-activation)