Prospective Non-comparative Study to Assess the Efficacy, the Safety and the Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea Syndrome in European Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 12
- 主要终点
- Efficacy : Change from baseline Apnea Hypopnea Index (AHI) at 1 month
研究概览
简要总结
This study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in European adult patients without cardiovascular and/or respiratory comorbidities/disorders.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with newly diagnosed OSA (5≤AHI≤30 ev/h) or for whom treatment has failed (CPAP, mandibular repositioning device), or patients with snoring only (5<AHI)
- •BMI≤30kg/m²
- •Patient with good motivation to use the nasal device,
- •Informed consent signed,
- •Patient with social protection.
排除标准
- •Cardiovascular comorbidities (resistant hypertension, recurrent atrial fibrillation, left ventricular failure, coronary heart disease and stroke),
- •Respiratory comorbidities (respiratory failure, chronic obstructive pulmonary disease (COPD),
- •Patient with one or more documented contraindication to use Nastent™,
- •no regular partner,
- •contraindication for sleep endoscopy,
- •Psychiatric or neurological disorders (epilepsy),
- •Progressive cancer or chronic inflammatory disease,
- •AHI including more than 5 central apnea per hour,
- •Allergy to one component of Nastent™.
研究组 & 干预措施
Device : nasal airway stent
Patients with OSA or snoring use the nasal airway stent nastent™ each night for sleeping. The device is a tube-shaped medical device that is inserted from the nose and the tip of the tube reaches the soft palate. The inserted tube aids breathing by preventing the obstruction of the airway which causes poor sleep, frequent awakening during sleep and snoring.
干预措施: nastent™ (Device)
结局指标
主要结局
Efficacy : Change from baseline Apnea Hypopnea Index (AHI) at 1 month
时间窗: 1 month
The Apnea Hypopnea Index (number of apnea and hypopnea per hour) will be measured by respiratory polygraph on OSA patients subgroup at baseline and after 1 month of nastent™ use to assess the efficacy of treatment.
Efficacy : change from baseline Snoring Intensity at 1 month
时间窗: 1 month
The snoring intensity will be evaluated by bed-partner of snorers and OSA patients using a Visual Analogue Scale (0-100 mm) at baseline and after 1 month of nastent™ use to assess the efficacy of treatment.
次要结局
- Observance(1 month)
- Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)(1 month)
- Change from baseline Sleepiness at 1 month(1 month)
- Adverse Events [Safety and Tolerability](1 month)
- Change from baseline Nasal Obstruction at 1 month(1 month)
- Physician satisfaction(1 month)