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NCT Number: NCT05822128

Alternative Epworth Sleepiness Scale ESS-ALT in French

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.

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Key information

Conditions

Excessive Daytime Sleepiness Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Charles Foix, Ivry-sur-Seine, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test of an alternative Epworth Sleepiness Scale ESS-ALT in French

Other

Seniors recruited into the study will test the Epworth Alternate Sleepiness Scale -ALT

Primary outcomes

  1. 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

  1. Study of the correlation between the results of the French ESS-ALT and polysomnography data

    Time frame: 24 hours

    Statistical comparison to identify the intrinsic validity of the ESS-ALT

  2. Study of the correlation between the results of the French ESS-ALT and MSLT (Multiple Sleep Latency Test) data

    Time frame: 24 hours

    Statistical comparison to identify the intrinsic validity of the ESS-ALT

  3. intrinsic validity of the ESS-ALT in French

    Time frame: 24 months

    Statistical comparison to identify the intrinsic validity of the ESS-ALT

  4. Study of the correlation between the ESS-ALT cohort in French and the ESS-ALT cohort in Germany

    Time frame: 24 months

    Statistical comparison to identify the intrinsic validity of the French version of ESS-ALT

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: SOMNOLD

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2023
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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