Alternative Epworth Sleepiness Scale ESS-ALT in French

Excessive Daytime Sleepiness Clinical Trial

— SOMNOLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05822128
• Other study ID #: APHP230377
• Status: Completed
• Start date: June 28, 2023
• Est. completion date: October 20, 2023

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 20, 2023
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Excessive Daytime Sleepiness
• Sleepiness

Intervention

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

Locations

Country	Name	City	State
France	Hospital Charles Foix	Ivry-sur-Seine
France	service des pathologies du sommeil, hôpital Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	intrinsic validity of the ESS-ALT in French	Statistical comparison to identify the intrinsic validity of the ESS-ALT	24 months
Secondary	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