Prevalence of Obesity Hypoventilation Syndrome in Subjects With Obesity Referred to Clinical (Medical Analysis) Laboratories for Regular Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,004
- 试验地点
- 5
- 主要终点
- Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis.
研究概览
简要总结
Rationale of the "BIO-OHS" study (Prevalence of Obesity Hypoventilation Syndrome):
The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Actually, this prevalence has been assessed in patients referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in patients already diagnosed with sleep apnea. The purpose of this study is to determine the prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical laboratories for regular follow-up medical analysis.
详细描述
No additional description
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •18 years old ans more
- •BMI over 30 kg/M2
- •Stable state (respiratory, metabolic and cardio-vascular) for the last 2 months
- •Addressed to a clinical labs for a blood check-up whatever the prescription
排除标准
- •No social security
- •Non cooperative patient, as judged by the investigator
结局指标
主要结局
Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis.
时间窗: From date of inclusion until the end of the study currently planned (up to 2 years)
OHS prevalence, validated by arterial blood gases analysis, will be assessed by the percentage of patients with OHS among all patients included in the study
次要结局
- Sensitivity and specificity of plasmatic [HCO3-] to detect OHS(From date of inclusion to the end of the study currently planned (2 years))
- Prevalence of metabolic and cardiovascular comorbidities in patients with OHS(From date of inclusion to the end of the study currently planned (2 years))
- To determine which medical specialties referred patients with OHS to clinical labs(From date of inclusion to the end of the study currently planned (2 years))
- Incidence of serious health events at 1 and 2-year follow-up(From time of OHS diagnostic to 1 and 2-year follow-up)