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临床试验/NCT05822128
NCT05822128已完成不适用

Sleepiness in the Elderly: Validation of the Alternative Epworth Sleepiness Scale ESS-ALT in French

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年6月28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
102
试验地点
2
主要终点
Validation of the alternative Epworth Daytime Sleepiness Scale -ALT adapted to the elderly and geriatric population in French

研究概览

简要总结

The Epworth Sleepiness Scale (ESS) is undoubtedly the most commonly used tool in daily clinical practice to assess daytime sleepiness in patients of all ages by means of a self-administered questionnaire.

In elderly subjects, the clinician is often confronted with difficulties in accurately estimating the ESS score and measuring subjective daytime sleepiness. Indeed, according to Onen et al, the ESS tends to underestimate the prevalence of sleep disorders in the geriatric population, mainly due to non-response to problematic items, namely:

  • Item 3: Sitting, inactive in a public place (cinema, theater, meeting)
  • Item 8: In a car that has been stopped for a few minutes.

In order to overcome this problem, Janine Gronewold's German team has developed and begun work on the validation of an alternative version of the ESS, the ESS-ALT, adapted to the population of interest, in German.

The aim of the present work is to adapt the ESS-ALT in French, then to study its correlation with sleep data recorded by nocturnal polysomnography, and among the secondary objectives, to correlate it with sleep latency during iterative sleep latency tests, in order to propose to the clinician a simple, reproducible tool, allowing to measure daytime sleepiness in elderly subjects.

详细描述

Developed in 1991 by Dr. Johns at the University of Melbourne and modified by him in 1997, the Epworth Sleepiness Scale (ESS) is undoubtedly the most commonly used tool in daily clinical practice to assess daytime sleepiness in patients of all ages by means of a self-administered questionnaire.

In elderly subjects, the clinician is often confronted with difficulties in accurately estimating the ESS score and measuring subjective daytime sleepiness. Indeed, according to Onen et al, the ESS tends to underestimate the prevalence of sleep disorders in the geriatric population, mainly due to non-response to problematic items, namely:

  • Item 3: Sitting, inactive in a public place (cinema, theater, meeting)
  • Item 8: In a car that has been stopped for a few minutes.

In order to overcome this problem, Janine Gronewold's German team has developed and begun work on the validation of an alternative version of the ESS, the ESS-ALT, adapted to the population of interest, in German.

The aim of the present work is to adapt the ESS-ALT in French, then to study its correlation with sleep data recorded by nocturnal polysomnography, and among the secondary objectives, to correlate it with sleep latency during iterative sleep latency tests, in order to propose to the clinician a simple, reproducible tool, allowing to measure daytime sleepiness in elderly subjects

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient 65 years of age and older
  • Consulting for sleep disorders
  • Enrolled in a social security system or entitled to it
  • Patient informed and having expressed his non-opposition to participate in the research

排除标准

  • Severe psychiatric or cognitive disorders that do not allow the completion of examinations/questionnaires
  • Patients who are dependent for all acts of daily life
  • Patients with a very short life expectancy
  • Patients under guardianship or curatorship
  • Patients under AME
  • Patients whose first language is not French
  • Patients with visual or cognitive impairments that make reading impossible

结局指标

主要结局

Validation of the alternative Epworth Daytime Sleepiness Scale -ALT adapted to the elderly and geriatric population in French

时间窗: 24 hours

forward and backward translation" between English and French, and correlation with the ESS sleepiness scale.

次要结局

  • Study of the correlation between the results of the French ESS-ALT and polysomnography data(24 hours)
  • Study of the correlation between the ESS-ALT cohort in French and the ESS-ALT cohort in Germany(24 months)
  • intrinsic validity of the ESS-ALT in French(24 months)
  • Study of the correlation between the results of the French ESS-ALT and MSLT (Multiple Sleep Latency Test) data(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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