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NCT05822128: SOMNOLD
Alternative Epworth Sleepiness Scale ESS-ALT in French
trial testing Test of an alternative Epworth Sleepiness Scale ESS-ALT in French in Excessive Daytime Sleepiness in 102 participants. Completed in 20 October 2023.
19 October 2023
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 102 |
| Start date | 28 June 2023 |
| Primary completion | 19 October 2023 |
| Estimated completion | 20 October 2023 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Test of an alternative Epworth Sleepiness Scale ESS-ALT in French
Conditions studied
- Excessive Daytime Sleepiness — all drugs for Excessive Daytime Sleepiness →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
65 and older, any sex, with Excessive Daytime Sleepiness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05822128
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05822128 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 27 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05822128.
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