Evolution of the Treatment of Rare Hypersomnias in a Reference Center Certified Since 2005 (EPHyRa)
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).
연구 개요
상세 설명
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).
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Marie Benhammani-Godard
- 전화번호: 0033158411190
- 이메일: marie.godard@aphp.fr
연구 연락처 백업
- 이름: Alexandre ROUEN
- 전화번호: +33 (0)1 42 64 86 26
- 이메일: alexandre.rouen@aphp.fr
연구 장소
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IDF
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Paris, IDF, 프랑스, 75014
- Sleep and Vigilance Center, Hôtel-Dieu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients diagnosed with central hypersomnia and diagnosed and/or followed-up at our site.
설명
Inclusion Criteria:
- Patients who have had at least one consultation or examination at the Sleep and Vigilance Center at Hôtel-Dieu since January 1, 2005;
- Patients diagnosed with narcolepsy (type 1 or type 2) or idiopathic hypersomnia;
- Adult patients (aged 18 or over);
- Patients who have not objected to the processing of their data.
Exclusion Criteria:
- Minors;
- Patients who object to the processing of their data;
- Patients under guardianship or conservatorship.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: OTHER
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Central hypersomnia
Patients diagnosed with central hypersomnia |
Non applicable |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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.
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Annual percentage of patients taking at least two treatments for their central hypersomnia.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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
기간: 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.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Alexandre ROUEN, APHP
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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