Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medartis AG
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Reduction of initial AHI by ≥20%
研究概览
简要总结
Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
详细描述
The new OSAS Implant is intended for use in the palate (hard and soft palate/ see picture above) in order to stiffen and stabilize the soft palate, which may reduce the severity of airway obstructions and of snoring in patients suffering from OSA (Obstructive Sleep Apnea). Indications for use of the System include: symptomatic, habitual, social snoring due to palatal flutter or upper airway obstruction primarily caused by the retropalatal obstruction. The System is labeled for use by physicians only.
The primary endpoint is the Apnea-Hypopnea-Index (AHI) in the 90 days follow-up.
Study hypothesis: Reduction of initial AHI ≥20%
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study patients must meet all of the following inclusion criteria:
- •Socially disturbing snoring with/without obstructive sleep apnea syndrome
- •Predominantly retropalatal obstructions established by ApneaGraph ≥60%, sleep nasendoscopy or successful application of the Velumount palatal device
- •Findings for predominantly retropalatal obstructions in ENT-examination:
- •No tonsils or tonsils grade I - II
- •Normal finding of larynx and tongue base
- •No lingual tonsil hypertrophy
- •ASA (American Society of Anaesthesiology, 1963) criteria I or II
- •Body mass index (BMI) < 33 kg/m2
- •Age > 18 yrs
- •Fix bed partner
- •Ability to read and understand the patient's information
排除标准
- •Previous Pillar implants
- •Previous airway surgery other than nasal, adenoid, tonsil or UPPP
- •Presence of other sleep disorders
- •Psychiatric disorders
- •Neurological disorders (e.g. Cerebrovascular injury)
- •Dysmorphia of the cranial skeleton
- •Pregnancy or breastfeeding
- •Known hypersensitivity to nitinol
- •Participation in another clinical study
结局指标
主要结局
Reduction of initial AHI by ≥20%
时间窗: 90days
The primary endpoint is the Apnea-Hypopnea-Index (AHI) at the 90 days follow-up. Study hypothesis: Reduction of initial AHI ≥20%. AHI is measured using cardio-respiratory polygraphy. Two measurements are performed before treatment and at 90 days follow-up in order to reduce effects from night-to-night variability.
次要结局
- Reduction of initial snoring index ≥30%(90days)