Excessive Daytime SleepinessSOMNOLDNCT05822128
Alternative Epworth Sleepiness Scale ESS-ALT in French
An observational study of Excessive Daytime Sleepiness, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Excessive Daytime Sleepiness
- What is being tested?
- Test of an alternative Epworth Sleepiness Scale ESS-ALT in French
- How many people
- 102 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Jun 2023to 20 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Seniors with suspected sleep disorders referred for assessment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospital Charles Foix
Ivry-sur-Seine, 94205
service des pathologies du sommeil, hôpital Pitié Salpêtrière
Paris, 75013
About this study
Official title: 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:
Read more
- 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.
Read the 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
- Conditions
- Excessive Daytime Sleepiness
- Being tested
- Test of an alternative Epworth Sleepiness Scale ESS-ALT in French
- Keywords
- Excessive daytime sleepiness, Elderly, Epworth Sleepiness Scale
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of an alternative Epworth Sleepiness Scale ESS-ALT in FrenchOther
Seniors recruited into the study will test the Epworth Alternate Sleepiness Scale -ALT
| Study group | Role | What they receive |
|---|---|---|
| Seniors with suspected sleep disorders referred for assessment | Seniors with suspected sleep disorders referred for assessment Receives: Other: Test of an alternative Epworth Sleepiness Scale ESS-ALT in French |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (4)
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
Measured: 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
Measured: 24 hours
intrinsic validity of the ESS-ALT in French
Statistical comparison to identify the intrinsic validity of the ESS-ALT
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start28 Jun 2023
- Primary completion19 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Daytime SleepinessStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822128
- Sponsor's protocol ID
- APHP230377
- Acronym
- SOMNOLD
- Status last verified
- Nov 2023
- First submitted
- 27 Mar 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleepiness in the Elderly: Validation of the Alternative Epworth Sleepiness Scale ESS-ALT in French
- ClinicalTrials.gov ID
- NCT05822128
- Acronym / sponsor ID
- SOMNOLD / APHP230377
- Conditions
- Excessive Daytime Sleepiness
- Keywords
- Excessive daytime sleepiness, Elderly, Epworth Sleepiness Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seniors with suspected sleep disorders referred for assessment | – | Other: Test of an alternative Epworth Sleepiness Scale ESS-ALT in FrenchSeniors with suspected sleep disorders referred for assessment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Seniors with suspected sleep disorders referred for assessment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test of an alternative Epworth Sleepiness Scale ESS-ALT in FrenchSeniors recruited into the study will test the Epworth Alternate Sleepiness Scale -ALT | Other | Seniors with suspected sleep disorders referred for assessment |
Primary outcome
Validation of the alternative Epworth Daytime Sleepiness Scale -ALT adapted to the elderly and geriatric population in French
Time frame: 24 hours
forward and backward translation" between English and French, and correlation with the ESS sleepiness scale.
4 secondary outcomes
Study of the correlation between the results of the French ESS-ALT and polysomnography data
Time frame: 24 hours
Study of the correlation between the results of the French ESS-ALT and MSLT (Multiple Sleep Latency Test) data
Time frame: 24 hours
intrinsic validity of the ESS-ALT in French
Time frame: 24 months
Study of the correlation between the ESS-ALT cohort in French and the ESS-ALT cohort in Germany
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Excessive Daytime Sleepiness, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the alternative Epworth Daytime Sleepiness Scale -ALT adapted to the elderly and geriatric population in French (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.