Clinical trial NCT05822128: Alternative Epworth Sleepiness Scale ESS-ALT in French
Official title: Sleepiness in the Elderly: Validation of the Alternative Epworth Sleepiness Scale ESS-ALT in French
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Excessive Daytime Sleepiness
Keywords: Excessive daytime sleepiness
Elderly
Epworth Sleepiness Scale
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 102
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Seniors with suspected sleep disorders referred for assessment

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

Eligibility criteria: 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

Primary outcomes:
measure: Validation of the alternative Epworth Daytime Sleepiness Scale -ALT adapted to the elderly and geriatric population in French
timeFrame: 24 hours
Secondary outcomes:
measure: Study of the correlation between the results of the French ESS-ALT and polysomnography data
timeFrame: 24 hours
measure: Study of the correlation between the results of the French ESS-ALT and MSLT (Multiple Sleep Latency Test) data
timeFrame: 24 hours
measure: intrinsic validity of the ESS-ALT in French
timeFrame: 24 months
measure: Study of the correlation between the ESS-ALT cohort in French and the ESS-ALT cohort in Germany
timeFrame: 24 months
Other outcomes:
Locations:
city: Ivry-sur-Seine
country: France
facility: Hospital Charles Foix
city: Paris
country: France
facility: service des pathologies du sommeil, hôpital Pitié Salpêtrière
Study officials:
References: