Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medartis AG
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- AHI reduction
研究概览
简要总结
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study.
详细描述
The clinical study is designed as single center, prospective, non-randomized and non-blinded clinical study. Since the surgical procedure is independent of the population a single center study is applied. A double-blind study is not possible considering the implantation procedure with the surgeon always knowing if the device is set. Therefore, the study is designed to be non-randomized and non-blinded as a pilot trial.
To reduce bias and other influences of single surgeon skills a principal investigator and one investigator are part of the clinical study. Further, subjects with previous treatments such as Pillar implant or previous airway surgery other than nasal, adenoid, tonsil or UPPP are excluded from the clinical study. A double-blind study is not possible considering the implantation procedure with the surgeon always knowing if the device is set. Therefore, the study is designed to be non-randomized and non-blinded as a pilot trial.
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
- •• Socially disturbing snoring and obstructive sleep apnea syndrome with AHI≥10/h
- •Predominantly retropalatal obstructions established either by:
- •Drug-induced sedation nasendoscopy
- •or ApneaGraph ≥60% (optional)
- •or successful application of the Velumount palatal device (optional)
- •Findings for predominantly retropalatal obstructions in ENT-examination:
- •No tonsils or tonsils grade I
- •Normal finding of larynx and tongue base, no omega-shaped epiglottis
- •No lingual tonsil hypertrophy
- •ASA (American Society of Anaesthesiology, 1963) classes I or II
- •Body mass index (BMI) < 30 kg/m2
- •Age > 18 yrs
- •Fix bed partner
- •Ability to read and understand the patient's information
排除标准
- •• Previous Pillar implants
- •Medartis palatinal implant (from previous phase I study)
- •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
- •Recurrent tonsillitis with prescription of antibiotics during the last 2 years (≥3x/year)
- •Omega-shaped epiglottis
- •Lingual tonsil hypertrophy
- •Kinking of the internal carotid artery
研究组 & 干预措施
Single center, prospective, non-randomized, non-blinded study
Implantation of 6 PPIS implants in each patient
干预措施: Implantation (Device)
结局指标
主要结局
AHI reduction
时间窗: 3 months post-op
AHI reduction
次要结局
未报告次要终点