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临床试验/NCT06141967
NCT06141967已完成不适用

Evaluating of the Impact of a Connected and Non-intrusive Device in Improving the Screening of Sleep Apnea Syndrome and the Addressing of Potentially Pathological Patients in Hospital Environment

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
2
主要终点
patients real positive for each screening technique

研究概览

简要总结

Diabetes, obesity and metabolic syndrome are closely linked to sleep apnea syndrome. Indeed, diabetic and/or obese patients present an increased risk of sleep apnoea syndrome (SAS), with a prevalence estimated at between 10 and 22%, depending on the study, and most of them requiring treatment with Continuous Positive Airway Pressure (CPAP). In this sub-population of patients, only between 40% and 50% benefit from CPAP.

详细描述

There is therefore an under-referral of diabetic patients to treatment, perhaps linked to the way care is organized, which clogs up the circuit and slows down or even prevents access to care. The investigators would like to test a new organization of care to facilitate and intensify this screening.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
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

入选标准

  • Adult patients over 18 years old
  • Diabetes Mellitus (Type 1 or 2), or obesity (BMI>30kg/m²) or metabolic syndrome
  • Hospitalized for at least one night in the Endocrinology department
  • Affiliated or entitled to a social security scheme
  • Having received informed information about the study and having co-signed, with the investigator, the informed consent form for participation in the study

排除标准

  • Known and/or treated OSAS-type respiratory pathology
  • No signature of the informed consent form
  • Minor or adult patients under guardianship or curatorship

结局指标

主要结局

patients real positive for each screening technique

时间窗: Day 2

Percentage of patients real positive for each screening technique: BERLIN and EPWORTH score and Withings Sleep Analyzer addressed for polysomnography

次要结局

  • Nurse's satisfaction with the use of Withings Sleep Analyzer(3 months)
  • Patient's experience with the use of Withings Sleep Analyzer(Day 2)
  • Number of tests(Day 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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