Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-31 @ 2:14 PM
Study NCT ID:
NCT05822128
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternative Epworth Sleepiness Scale ESS-ALT in French
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Sleepiness in the Elderly: Validation of the Alternative Epworth Sleepiness Scale ESS-ALT in French
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOMNOLD
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: