Inspire UAS High AHI/High BMI Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability)
研究概览
简要总结
The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.
详细描述
This post-approval study is a condition of FDA approval and will collect long-term safety and effectiveness data on an expanded population that includes patients with very severe obstructive sleep apnea (65<AHI≤100 events/hr), as well as those with a higher BMI (32<BMI≤40 kg/m2). Participants will be implanted with a commercially available Inspire UAS System. In addition, participants will receive a patient remote which is used to initiate therapy each night.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age;
- •Subject has a diagnosis of severe OSA (65 ≤ AHI ≤ 100) based on a recent sleep study (within 12 months) OR Subject has a diagnosis of moderate to severe OSA (15≤AHI≤100) AND a baseline Body Mass Index of 32<BMI≤40 kg/m2;
- •Subject has documented failure of, or intolerance to, positive airway pressure treatments (such as CPAP or BPAP machines; NOTE: PAP failure is defined as an inability to eliminate OSA (AHI > 15 despite PAP usage). PAP intolerance is defined as the inability to use PAP (> 5 nights per week, 4 hours of usage per night) or unwillingness to use PAP (e.g. patient returns the PAP system after attempting to use it).
- •Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
- •Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the study;
- •Subject is willing and able to provide informed consent.
排除标准
- •Subject has a combination of central + mixed apneas > 25% of the total apnea-hypopnea index (AHI) based on a recent sleep study (within 12 months);
- •Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
- •Subject has any condition or procedure that has compromised neurological control of the upper airway;
- •Subject is unable or does not have the necessary assistance to operate the patient remote;
- •Subject is pregnant or plans to become pregnant;
- •Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
- •Subject has a terminal illness with life expectancy < 12 months;
- •Any other reason the investigator deems the subject is unfit for participation in the study.
结局指标
主要结局
Incidence of Procedure and/or Device Related Adverse Events (Safety and Tolerability)
时间窗: 5 years post-implant
Procedure-related Adverse Events; Device-related Adverse Events
次要结局
- Change in Apnea Hypopnea Index Over Time(5 years post-implant)
- Body Mass Index(5 years post-implant)
- Change in Oxygen Desaturation Index (ODI) Over Time(5 years post-implant)
- Change in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) Over Time(5 years post-implant)
- Change in Epworth Sleepiness Scale (ESS) Over Time(5 years post-implant)