Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
研究概览
简要总结
This study evaluates the utility and reliability of Somnocheck micro Weinmann for obstructive sleep apnea syndrome (OSAS) screening in patients affected by resistant systemic arterial hypertension. Results are compared with a modified portable sleep apnea testing (type III portable monitoring: Somnocheck 2 Weinmann).
详细描述
OSAS is a syndrome characterized by the partial or total collapse of the high airways which determines snore, airflow limitation, hypopnea and apnea.These events cause desaturations, daytime sleepiness and an increased risk of cardio and cerebral vascular diseases.
OSAS's prevalence is estimated between 64-83% among patients affected by resistant arterial hypertension; therefore OSAS's screening is mandatory during the clinical work-up of these patients.
This study is a randomized, interventional, spontaneous, exploratory, cross-over and monocentric trial, which assesses the utility and reliability of the reduced cardio-respiratory monitoring (type IV portable monitoring: Somnocheck micro Weinmann) to estimate the prevalence of OSAS among patients affected by resistant systemic arterial hypertension. The results are compared with a complete cardio-respiratory monitoring (type III portable monitoring: Somnocheck 2 Weinmann).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Resistant Arterial Hypertension
- •Patients must sign the informed consent
排除标准
- •atrial fibrillation with haemodynamic instability
- •congestive hearth failure,
- •BMI>45 kg/m2,
- •respiratory failure
- •renal or liver failure,
- •implantable cardioverter-defibrillator (ICD),
- •pacemaker (PM),
- •previous diagnosis of OSAS,
- •pregnancy,
- •breastfeeding,
- •patients must not be already enrolled in other clinical trial.
研究组 & 干预措施
Screening device-Traditional device
The patients included in the A Group will be studied during the first night with the screening device (type IV portable monitoring Somnocheck micro Weinmann) and with the traditional one during the following night.
干预措施: type IV portable monitoring (Somnocheck micro Weinmann) (Device)
Traditional device-Screening device
The patients included in the B Group will be studied during the first night with the traditional device and with the screening one (type IV portable monitoring Somnocheck micro Weinmann) during the following night.
干预措施: type IV portable monitoring (Somnocheck micro Weinmann) (Device)
结局指标
主要结局
Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
时间窗: These two procedures must be done in the same patient within 5 days
Apnea hypopnea index (AHI) differences between screening device and the traditional diagnostic one.
次要结局
- Number of Participants with cardiovascular abnormalities 1(Cardiovascular assessment must be done within 6 months before the sleep studies.)
- Number of Participants with cardiovascular abnormalities 2(Cardiovascular assessment must be done within 6 months before the sleep studies.)
研究者
Francesco Tavalazzi
Medical Doctor
IRCCS Azienda Ospedaliero-Universitaria di Bologna