Tongue Advancement for Obstructive Sleep Apnea. An Evaluation fo the Aspire Medical Advance System.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Demonstrate the feasibility of tongue stabilization using the Advance™ System. Product implantation and stabilization of the tongue using the Advance™system will be measured by Pharyngoscopy and Cephalogram
研究概览
简要总结
The objective of this study is to assess the feasibility, safety and effectiveness of tongue stabilization using Aspire Medical Advance™ System for the treatment of obstructive sleep apnea (OSA). Success is defined as a statistically significant reduction in AHI measured by polysomnography (PSG) from baseline to 6 months.
详细描述
Obstructive sleep apnea (OSA) is a major health problem in the United States and can result in excessive daytime sleepiness and cardiovascular problems. The primary treatment for OSA today is continuous positive airway pressure (CPAP). Many patients however are unable to tolerate sleeping with a CPAP machine. Surgery is one of the main treatment options available today to these CPAP-intolerant patients. However, current methods of sleep surgery are painful, morbid, and/or lack decent effectiveness.
This trial will measure the effectiveness of the Advance System, an implantable medical device to treat OSA. In the trial, patients who meet the study entry criteria receive a baseline sleep study (PSG). The Advance System is then implanted and 6 months after implantation, another PSG is performed. The trial will compare the baseline and the 6 month apnea-hypopnea indices
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of obstructive sleep apnea with AHI 15-50 measured within a year prior to enrollment with no major change in BMI
- •Bewteen 20 and 65 years old
- •Body Mass Index (BMI) ≤ 32
- •Patient has been offered CPAP and has refused or failed to continue CPAP treatment
- •Identified evidence of airway collapse, primarily at the base of the tongue
- •Signed informed consent to participate in this clinical study
排除标准
- •Prior OSA surgery except tonsillectomy, nasal surgery and uvulopalatopharyngoplasty; no airway surgery within 3 months prior to enrollment.
- •Airway collapse at the level of the soft palate (palatal collapse).
- •Enlarged tonsils (3+ and 4+)
- •Anatomy unable to accommodate the implant
- •Severe mandibular deficiency/retrognathia
- •Unable and/or not willing to comply with treatment follow-up requirements.
- •Pregnancy. (Female subjects of childbearing potential must have a negative pregnancy test prior to enrollment and should maintain adequate contraception during the study)
- •Breastfeeding women
- •Active systemic infection
- •Allergy to any medication used during implantation
- •Previous history of neck or upper respiratory tract cancer
- •History of radiation therapy to neck or upper respiratory tract
- •Dysphagia
- •Major cardiovascular and pulmonary disorders
- •Other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment
- •Enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study
结局指标
主要结局
Demonstrate the feasibility of tongue stabilization using the Advance™ System. Product implantation and stabilization of the tongue using the Advance™system will be measured by Pharyngoscopy and Cephalogram
时间窗: 3 months
Evaluate the safety of the Advance™ System 3 Months after implantation.
时间窗: 3 months
Compare baseline and 6 month apnea-hypopnea indices as measured by PSG studies.
时间窗: 6 months
次要结局
- Functional Outcomes of Sleep Questionnaire (FOSQ) measured at 3 Months post-implantation(3 months)
- Epworth Sleepiness Scale (ESS) measured at 3 Months post-implantation(3 months)