Inspire® Upper Airway Stimulation System (UAS): Post-Approval Study Protocol Number 2014-001
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 127
- 试验地点
- 28
- 主要终点
- Long-term Device-Related SAEs
研究概览
简要总结
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.
详细描述
This is a multi-center, prospective, single-arm study conducted under a common protocol. Each subject will serve as their own control. Each subject will be followed for 5 years from date of implant.
Potential study subjects will be considered for study participation and consented once pre-implant screening and implant qualification process have been completed. This includes an in-lab PSG, surgical consultation, and a drug-induced sleep endoscopy procedure.
This study will collect pre-operative baseline data including, verification of ineffective CPAP treatment, PSG information, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected.
Post-implant, procedure- and device-related adverse events, QoL questionnaires, Functional Tongue Exam, therapy usage and device adjustment data will be collected. In-lab PSG sleep study data will be collected during the 2-month and 1 & 3 year follow-up visits, home sleep tests will be conducted and data collected at the 6-month and 2, 4, & 5 year follow-up visits.
The subject population will consist of otherwise healthy men and women that are at least 22 years old and have: 1) Provided written informed consent to participate, 2) Indicated a willingness to comply with the study requirements for the specified follow-up duration, and 3) Met all inclusion and exclusion criteria of this protocol.
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 or have an established diagnosis of OSA (AHI >= 15) based on a prior sleep study
- •Documentation the subject not effectively treated with CPAP therapy. (Examples include non-compliance, discomfort, undesirable side effects, symptoms persist despite use). Subjects who have been prescribed, but refuse to try CPAP would be considered intolerant.
- •Age 22 or above
- •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
- •Contraindications:
- •Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
- •Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
- •Any condition or procedure that has compromised neurological control of the upper airway
- •Patients who are unable or do not have the necessary assistance to operate the patient remote
- •Patients who are pregnant or plan to become pregnant
- •Patients who will require magnetic resonance imaging (MRI)
- •Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system.
- •Additional exclusions for study purposes only:
- •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
Long-term Device-Related SAEs
时间窗: 5 Years Post-Implant
This safety endpoint is to assess long-term (5 years) safety via comparison of device-related SAEs with a performance goal of 24%. The objective at 5 years is to demonstrate the device-related SAE rate is no worse than the performance goal.
Therapy Specific AEs
时间窗: 12 Months Post-Implant
This safety endpoint is to evaluate the safety of the Inspire system in the treatment of sleep apnea by evaluating procedure- and device-related AEs occurring immediately post-implant through 12 months post-implant.
Long-term Therapy-Related AEs
时间窗: 5 Years Post-Implant
This safety endpoint is to assess long-term (5 years) safety via the description of all reported AEs, including all therapy- and procedure-related events.
次要结局
- Number of Acute AEs Reported with Newly Trained Physicians as Compared to Experienced Physicians(30 days post-implant)