Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Improvement in symptoms
研究概览
简要总结
Sleep apnea is a prevalent problem and references for the evaluation of this condition often exceeds the sleep clinic's capacity thus creating important delays in the patients' care.
The overall goal of this project is to assess the feasibility and the non-inferiority of integrating a clinical nurse, or supernurse, to the initial consultation team.
The hypothesis is that the integration of a clinical nurse to the sleep clinic's evaluation team is non inferior in terms of patients' outcomes such as improvement of symptoms and quality of life as well as adherence to treatment.
This study is supported by funding dedicated to teaching and research activities related to sleep-disordered breathing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to the ''Institut Universitaire de Cardiologie et Pneumologie de Québec'' 's sleep clinic who have undergone a cardiorespiratory polygraphy.
- •Body mass index (BMI) between 27-35 kg/m2;
- •Apnea-Hypopnea Index (ADI) equal or above 20 events per hour with less than 5 events per hour of central origin;
- •Oxygen Desaturaton Index (ODI) equal or above 10 events per hour;
- •Percentage of time spent below 90% of oxygen saturation equal or less than 10%
排除标准
- •Patients not meeting the above inclusion criteria.
结局指标
主要结局
Improvement in symptoms
时间窗: Assessed at six months
Based on the Epworth Sleepiness scale (ranging from 0 to 24 points, higher values indicates increased sleepiness)
次要结局
- Mandibular advancement device treatment adherence(Assessed at six months)
- Positive pressure treatment adherence(Assessed at six months)
- Weight loss treatment adherence(Assessed at six months)
- Improvement in quality of life(Assessed at six months)
- Positional therapy(Assessed at six months)
研究者
Annie C Lajoie
MD
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec