Therapy Adherence in Different Settings of Automatic Positive Airway Pressure (APAP) Therapy Initiation in Patients With Obstructive Sleep Apnea (OSA): Comparison Between in Sleep-lab vs. at Home Environment.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Number of usage hours of of positive airway pressure therapy per night
研究概览
简要总结
Primary hypothesis:
The objective compliance ( # of hours per night of APAP therapy) is higher in patients who get the APAP treatment initiation at home due to the fact that they get better support by telemetric control and the possibility of prompt interventions.
Secondary hypothesis:
Based on the higher support at the home APAP initiation the following parameters will be better in comparison to the standard supply in laboratory:
Objective measures:
- mask leakage
- pressure
- Apnea-Hypopnea-Index (AHI)
Subjective measures:
- quality of life
- sleepiness
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent from patients after verbally and written informing
- •Age between 18 and 80 Years
- •obstructive sleep apnea syndrome (OSAS) with an AHI > 15/h and without previous therapy
排除标准
- •Intolerance to wear the PAP therapy mask
- •sleep breathing disorders (SBD) with central apneas > 20% and other sleep disorders
- •disabilities who prevents the wear of a therapy mask
- •initiated PAP therapy
- •pre-treatment of OSAS incl. UPPP (uvulo palato pharyngo plasty)
- •modified Mallampati Score T3 and T4
- •participation on clinical studies 4 weeks before start of the study
- •known or acute psychiatric/neurological or psychological disorders, who impairs the compliance to take part of the study.
- •chronical or new clinically significant pneumological or cardiovascular disease (exception: effectively therapies of hypertension, cardiac arrhythmia and coronal cardiac disease)
- •acute internistic disease
- •neuromuscular disease
- •condition after Apoplexy
- •oncological disease in recent 5 years
- •drug/alcohol consumption
- •consumption of von psychotropic drugs, hypnotics and other drugs who are able to influence the sleep/wake cycle
研究组 & 干预措施
APAP Home
initiation of APAP therapy in homely environment with additional continuous telemetric support.
干预措施: Automatic Positive Airway Pressure (APAP) initiation (Procedure)
APAP Lab
standard Initiation of APAP therapy in sleep laboratory.
干预措施: Automatic Positive Airway Pressure (APAP) initiation (Procedure)
结局指标
主要结局
Number of usage hours of of positive airway pressure therapy per night
时间窗: 6 month
次要结局
- Apnea Hypopnea Index [1 / hour of sleep)(6 month)
研究者
Prof. Dr. Ingo Fietze
Head of Sleep Lab
Charite University, Berlin, Germany