Alternative Epworth Sleepiness Scale ESS-ALT in French

NCT05822128 | Completed

• 1 other identifier: APHP230377
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Excessive Daytime Sleepiness

Keywords

Excessive daytime sleepiness; Elderly; Epworth Sleepiness Scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  24 hours

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

  24 hours

• intrinsic validity of the ESS-ALT in French

  24 months

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

  24 months

Study Arms (1)

Seniors with suspected sleep disorders referred for assessment

Seniors with suspected sleep disorders referred for assessment

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

Interventions

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

Seniors with suspected sleep disorders referred for assessment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Seniors with suspected sleep disorders referred for assessment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hospital Charles Foix

Ivry-sur-Seine, 94205, France

Location

service des pathologies du sommeil, hôpital Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 20, 2023
• Study Start: June 28, 2023
• Primary Completion: October 19, 2023
• Study Completion: October 20, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

FR (2)