Alternative Epworth Sleepiness Scale ESS-ALT in French (SOMNOLD)

Sleepiness in the Elderly: Validation of the 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.

Study Overview

• Status: Completed
• Conditions: Excessive Daytime Sleepiness
• Intervention / Treatment: Other: Test of an alternative Epworth Sleepiness Scale ESS-ALT in French

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 Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

• Study Contact: Name: Kiyoka Kinugawa, PhD; Phone Number: 01 49 59 47 53; Email: kiyoka.kinugawa@aphp.fr

Study Locations

• France
  • Ivry-sur-Seine, France, 94205
    • Hospital Charles Foix
    • Contact: Kiyoka Kinugawa, PhD; Phone Number: +33 1 49594753; Email: Kiyoka.kinugawa@aphp.fr
  • Paris, France, 75013
    • service des pathologies du sommeil, hôpital Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Seniors with suspected sleep disorders referred for assessment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Seniors with suspected sleep disorders referred for assessment	Other: Test of an alternative Epworth Sleepiness Scale ESS-ALT in French; Seniors recruited into the study will test the Epworth Alternate Sleepiness Scale -ALT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of the alternative Epworth Daytime Sleepiness Scale -ALT adapted to the elderly and geriatric population in French	forward and backward translation" between English and French, and correlation with the ESS sleepiness scale.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study of the correlation between the results of the French ESS-ALT and polysomnography data	Statistical comparison to identify the intrinsic validity of the ESS-ALT	24 hours
Study of the correlation between the results of the French ESS-ALT and MSLT (Multiple Sleep Latency Test) data	Statistical comparison to identify the intrinsic validity of the ESS-ALT	24 hours
intrinsic validity of the ESS-ALT in French	Statistical comparison to identify the intrinsic validity of the ESS-ALT	24 months
Study of the correlation between the ESS-ALT cohort in French and the ESS-ALT cohort in Germany	Statistical comparison to identify the intrinsic validity of the French version of ESS-ALT	24 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Actual): October 19, 2023
• Study Completion (Actual): October 20, 2023

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Epworth Sleepiness Scale; Excessive daytime sleepiness
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Sleepiness
• Other Study ID Numbers: APHP230377

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No