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临床试验/NCT02264431
NCT02264431Unknown不适用

Determinants of Nocturnal Respiratory Disorders of Obese Patients Referred to in a Specialized Center.

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Sleep breathing disorders

研究概览

简要总结

The main objective of the study is to identify the determinant of sleep characteristics of obese patients attempting a tertiary clinical center for obesity management, including bariatric surgery.

More accurately the questions addressed are:

  • What are the determinants of the sleep habits (sleep duration, chronotype) and of their evolution
  • What are the determinants of sleep breathing disorders (sleep apnea, obesity hypoventilation syndrome) and of their evolution

详细描述

Adult obese patients, attempting a tertiary medical center for the management of their obesity, are asked to participate in a cohort study. Data issued from routine clinical practice are collected.

Medical history and actual medical condition:

  • Type 2 or type 1 diabetes
  • Dyslipidemia
  • Hypertension
  • Cardiovascular diseases
  • Steatohepatitis/cirrhosis
  • Gastric disorders
  • Nutritional deficiency
  • Obstructive sleep apnea/Obesity hypoventilation syndrome

All patients who do not have a previously known sleep apnea syndrome are evaluated by nocturnal polygraphy.

Lifestyle and sleep habits, as well as social and economic characteristics, are assessed by questionnaires.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Class II or class III obesity (BMI ≥ 35 kg/m²). Only patients undergoing surgery to realize a second surgical line of management of their obesity may have a lower BMI, if the surgical recovery is motivated by a technical defect of the first assembly.

排除标准

  • Refusal to participate.

结局指标

主要结局

Sleep breathing disorders

时间窗: 5 years

Evolution of sleep breathing disorders during obesity management, especially after bariatric surgery

次要结局

  • Sleep habits(5 years)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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