Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea in High Risk Population in Hong Kong
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Validity of the new home sleep study device compare with conventional inpatient sleep study
研究概览
简要总结
Newer home sleep study device and algorithm provides an alternative for inpatient sleep study and improve the service provides to patients
详细描述
Purpose: Assess different potential algorithms to improve the service and cost utility for diagnosis and treatment of obstructive sleep apnea syndrome (OSAS) in patients with high pretest probability in Hong Kong.
Hypothesis
Newer home sleep study device and algorithm provides an alternative for inpatient sleep study Design: Prospective randomized study Subject: High pretest probability of OSAS patients referred to a tertiary centre.
Study instruments: a portable sleep study device, AutoCPAP and inpatient sleep monitoring system.
Interventions: comparison between 3 different algorithms of health service for OSA patients would be made: conventional in-patient sleep study, empirical treatment and home sleep study.
Main outcome measures: The primary outcome is the validity of the home sleep study device compare to inpatient sleep study. The secondary outcomes are the relative efficacy of different algorithms and the numbers of failed procedures in each algorithm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with high pretest probability of OSAS, i.e. ESS > 10 or symptomatic patients, with BMI > 23 and/or cranial facial features associated with OSA, as assessed by the attending respiratory physician in the respiratory clinic.
- •Patients aged between 18-65 years who agree to participate in the study.
排除标准
- •Pregnant women
- •Patients who refuse signing consent of the study
- •Do not have high pretest probability of OSAS
- •Refuse to have home sleep study
- •Refuse any treatment offered; or
- •Could not comply with the set up of home study.
结局指标
主要结局
Validity of the new home sleep study device compare with conventional inpatient sleep study
时间窗: 1 year
次要结局
- The relative efficacy between different algorithm(1 year)
- Failure rates in different algorithms which need to switch to the conventional algorithm(1 year)