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Evolution of the Treatment of Rare Hypersomnias in a Reference Center Certified Since 2005 (EPHyRa)

2026. november 5. frissítette: Assistance Publique - Hôpitaux de Paris

Central hypersomnias are rare diseases that include narcolepsy and idiopathic hypersomnia.

The Sleep and Vigilance Center at Hôtel-Dieu has been certified as a Rare Disease Reference Center (CRMR) for these conditions since 2005.

Scientific advances and changes to the ICSD (International Classification of Sleep Disorders) since 2005 (diagnostic criteria and drugs brought to market) have greatly improved the care of patients with central hypersomnia.

This retrospective and prospective study aims to evaluate how each advance translates into concrete terms in the care of patients followed at our center.

Main objective :

Determine whether new treatments are prescribed to replace treatments already on the market (reduction in prescriptions for treatments previously marketed) or whether they enable patients who have reached a therapeutic impasse to be treated (no reduction in prescriptions for treatments previously marketed).

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

Central hypersomnias are rare diseases that include narcolepsy and idiopathic hypersomnia.

The Sleep and Vigilance Center at Hôtel-Dieu has been certified as a Rare Disease Reference Center (CRMR) for these conditions since 2005.

Scientific advances and changes to the ICSD (International Classification of Sleep Disorders) since 2005 (diagnostic criteria and drugs brought to market) have greatly improved the care of patients with central hypersomnia.

This retrospective and prospective study aims to evaluate how each advance translates into concrete terms in the care of patients followed at our center.

Main objective :

Determine whether new treatments are prescribed to replace treatments already on the market (reduction in prescriptions for treatments previously marketed) or whether they enable patients who have reached a therapeutic impasse to be treated (no reduction in prescriptions for treatments previously marketed).

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

1500

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

  • Franciaország
    • IDF
      • Paris, IDF, Franciaország, 75014
        • Sleep and Vigilance Center, Hôtel-Dieu

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

Patients diagnosed with central hypersomnia and diagnosed and/or followed-up at our site.

Leírás

Inclusion Criteria:

  1. Patients who have had at least one consultation or examination at the Sleep and Vigilance Center at Hôtel-Dieu since January 1, 2005;
  2. Patients diagnosed with narcolepsy (type 1 or type 2) or idiopathic hypersomnia;
  3. Adult patients (aged 18 or over);
  4. Patients who have not objected to the processing of their data.

Exclusion Criteria:

  1. Minors;
  2. Patients who object to the processing of their data;
  3. Patients under guardianship or conservatorship.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Megfigyelési modellek: COHORT
  • Időperspektívák: OTHER

Kohorszok és beavatkozások

Csoport / Kohorsz
Beavatkozás / kezelés
Central hypersomnia

Patients diagnosed with central hypersomnia
Egyéb: Non applicable

Non applicable

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Ratio of the number of patients who were prescribed this treatment during the year to the number of patients who had at least one consultation at the center during the same year.
Időkeret: For the 1st time for prescriptions from Jan 1, 2005, to Dec 31, 2025. Then, every three years: prescriptions until Dec 31, 2028, Dec 31, 2031, and Dec 31, 2034, in order to take into account marketing of new treatments currently in phase 3

Ratio of the number of patients who were prescribed this treatment during the year to the number of patients who had at least one consultation at the center during the same year.

Annual change in prescriptions for each treatment
For the 1st time for prescriptions from Jan 1, 2005, to Dec 31, 2025. Then, every three years: prescriptions until Dec 31, 2028, Dec 31, 2031, and Dec 31, 2034, in order to take into account marketing of new treatments currently in phase 3
Number of days of treatment
Időkeret: For the 1st time for prescriptions from Jan 1, 2005, to Dec 31, 2025. Then, every three years: prescriptions until Dec 31, 2028, Dec 31, 2031, and Dec 31, 2034, in order to take into account marketing of new treatments currently in phase 3

Number of days of treatment: mean + standard deviation for patients who received this treatment during the year, median and quartiles.

Annual change in prescriptions for each treatment
For the 1st time for prescriptions from Jan 1, 2005, to Dec 31, 2025. Then, every three years: prescriptions until Dec 31, 2028, Dec 31, 2031, and Dec 31, 2034, in order to take into account marketing of new treatments currently in phase 3

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Annual percentage of patients taking at least two treatments for their central hypersomnia.
Időkeret: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.

Annual percentage of patients taking at least two treatments for their central hypersomnia.
This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Number of diagnoses made between 2005 and 2023 that were modified by the new ICSD criteria in 2023.
Időkeret: During first analyses

Number of diagnoses made between 2005 and 2023 that were modified by the new ICSD criteria in 2023.
During first analyses
Percentage of diagnoses made between 2005 and 2023 that were modified by the new ICSD criteria in 2023.
Időkeret: During first analyses

Percentage of diagnoses made between 2005 and 2023 that were modified by the new ICSD criteria in 2023.
During first analyses
Number of patients with an initial diagnosis of NT2 who were reclassified as NT1 due to the onset of cataplexy.
Időkeret: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.

Number of patients with an initial diagnosis of NT2 who were reclassified as NT1 due to the onset of cataplexy.
This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Percentage of patients with an initial diagnosis of NT2 who were reclassified as NT1 due to the onset of cataplexy.
Időkeret: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.

Percentage of patients with an initial diagnosis of NT2 who were reclassified as NT1 due to the onset of cataplexy.
This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Epworth scale
Időkeret: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.

Reduction in sleepiness (Epworth scale and wakefulness maintenance tests) average for each treatment and combination of treatments.
This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Wakefulness maintenance tests
Időkeret: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.

Reduction in sleepiness (Epworth scale and wakefulness maintenance tests) average for each treatment and combination of treatments.
This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Average age of these patients at the onset of cataplexy
Időkeret: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.

Average age of these patients at the onset of cataplexy
This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Average number of years between initial diagnosis and onset of cataplexy
Időkeret: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.

Average number of years between initial diagnosis and onset of cataplexy
This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Average number of years between first symptoms and onset of cataplexy.
Időkeret: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.

Average number of years between first symptoms and onset of cataplexy.
This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Adverse events collected during medical consultations
Időkeret: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.

Adverse events collected during medical consultations
This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Effects on other components of the pathologies
Időkeret: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.

Effects on other components of the pathologies (via IHSS scores, NSS, fatigue and brain fog scale, etc.).
This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Assistance Publique - Hôpitaux de Paris

Együttműködők

URC-CIC Paris Descartes Necker Cochin

Nyomozók

  • Kutatásvezető: Alexandre ROUEN, APHP

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. november 1.

Elsődleges befejezés (Becsült)

2036. november 1.

A tanulmány befejezése (Becsült)

2036. november 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. november 5.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 5.

Első közzététel (Tényleges)

2026. november 12.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. november 12.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 5.

Utolsó ellenőrzés

2026. november 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • APHP251690

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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