跳至主要内容
临床试验/NCT03344263
NCT03344263已完成不适用

Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年11月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Study of the reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP

研究概览

简要总结

It is a monocentric prospective pilot study in Poitiers University Hospital, specifically analyzing the vigilance disorders in the Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and their reversibility after 6 months of Continuous positive airways pressure (CPAP).

All subjects were administered a test of vigilance (Test of Attentional Performance) both before and after the 6 months of CPAP.

The main objective is the study of the reversibility of alertness disorders on the number of omissions in the subtest visual vigilance of the TAP ( (Test of Attentional Performance) at 6 months of CPAP in the OSAHS in patients with a memory complaint.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 20-70 years
  • •Memory disorders without memory problems in episodic memory
  • •Presence of polysomnography of a obstructive sleep apnea/hypopnea syndrome (OSAHS) requiring Continuous positive airways pressure
  • •Moderate OSAHS (Apnea Hypopnea Index ≥ 15 / hour with arousals ≥ 10)
  • •Severe OSAHS (Apnea Hypopnea Index ≥ 30 / h)

排除标准

  • •Age <20 years or ≥ 70 years
  • •Neurodegenerative disease (Alzheimer's disease, Parkinson's disease)
  • •Dysthyroidism
  • •Severe depression, schizophrenia, bipolar disorder
  • •Treatment with an effect on cognition: hypnotics, sedative
  • •Chronic Obstructive Pulmonary Disease
  • •Chronic alcoholism, other addictions
  • •Contraindications to Magnetic Resonance Imaging
  • •Refusal of equipment

研究组 & 干预措施

tests of attentional performance

Experimental

干预措施: tests of attentional performance (Diagnostic Test)

结局指标

主要结局

Study of the reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP

时间窗: After 6 months of continuous positive airways pressure in the OSAHS patient

Reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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