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Clinical Trials/NCT05822128
NCT05822128
Completed
Not Applicable

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

Assistance Publique - Hôpitaux de Paris2 sites in 1 country102 target enrollmentStarted: June 28, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
102
Locations
2
Primary Endpoint
Validation of the alternative Epworth Daytime Sleepiness Scale -ALT adapted to the elderly and geriatric population in French

Overview

Brief Summary

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.

Detailed Description

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 24 hours

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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