ORM Narval Mandibular Repositioning Device in the Second-line Treatment of Severe OSAH
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 360
- 试验地点
- 25
- 主要终点
- Percentage of patients with Apnea/Hypopnea Index (AHI) reduced by at least 50% compared to baseline measured by Polygraphy/Polysomnography (PG/PSG)
研究概览
简要总结
The purpose of this study is to evaluate the long-term efficacy, tolerance and compliance of ORM Narval Mandibular Repositioning Device (MRD) as a second-line treatment for patients with severe Obstructive Sleep Apnea Hypopnea (OSAH) syndrome who refuse or are intolerant to Continuous Positive Airway Pressure (CPAP) treatment.
详细描述
OSAH is a common condition which occurs in between 1 and 4% of the adult population. Respiratory obstruction may be complete (apnea) or incomplete (hypopnea). This disorder disturbs the architecture and quality of sleep, and is a known risk factor in the development of cardiovascular and metabolic diseases. CPAP is the standard treatment, however in some cases patients are unable to use it (rejection, intolerance, etc.). In such circumstances, treatment using a MRD may result in an improvement of symptoms.
Very few long-term clinical data are available on treatment of OSAH by MRD. This study should allow to have a precise and representative vision of 5 years results of ORM Narval MRD treatment in conditions of good practices (titration, controls of efficacy).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patient with severe OSAH (AHI > 30 or AHI of between 5 and 30 along with severe daytime sleepiness),
- •intolerant to or having refused CPAP therapy,
- •no dental, parodontal or articulatory contraindications,
- •no experience of any mandibular advancement device therapy,
- •medical insurance.
排除标准
- •severe psychiatric disorders or severe neuromuscular disorders
- •> 20% of central apneas during the baseline assessment,
- •severe OSAH with an AHI > 30 associated with another sleep pathology (narcolepsy with or without cataplexy, idiopathic hypersomnia, severe restless legs syndrome),
- •pregnant or breastfeeding woman,
- •Informed consent not signed,
- •patient requiring special protection such as patients with appointed guardians and patients without legal or administrative rights,
- •patient who is completely or partially edentulous
结局指标
主要结局
Percentage of patients with Apnea/Hypopnea Index (AHI) reduced by at least 50% compared to baseline measured by Polygraphy/Polysomnography (PG/PSG)
时间窗: 5 years
次要结局
- Sleep quality of life (Quebec Sleep Questionaire)(3 months, 2 years and 5 years)
- Fatigue score (Pichot questionaire)(3 months, 2 and 5 years)
- Percentage of patients who no longer suffer from severe daytime sleepiness (Epworth Sleepiness scale)(3 months, 2 years and 5 years)
- Percentage of patients who stopped the therapy for dento-maxillofacial side effects(6 months, 1, 2, 3, 4 and 5 years)
- Percentage of patients with AHI reduced by at least 50% compared to baseline measured by PG/PSG(3 months and 2 years)
- Percentage of patients with satisfactory compliance(3 months, 2 and 5 years.)