Evolution of the Treatment of Rare Hypersomnias in a Reference Center Certified Since 2005
NCT07930728, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evolution of the Treatment of Rare Hypersomnias in a Reference Center Certified Since 2005 | ClinicalTrials.gov |
| NCT number | NCT07930728 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 1,500 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris | ClinicalTrials.gov |
| Conditions | Narcolepsy Type 1, Narcolepsy Type 2, Narcolepsy and Hypersomnia, Hypersomnia, Idiopathic | ClinicalTrials.gov |
| Interventions | Non applicable | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | 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 | ClinicalTrials.gov |
| Primary | Number of days of 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: mean + standard deviation for patients who received this treatment during the year, median and quartiles. Annual change in prescriptions for each treatment | ClinicalTrials.gov |
| Secondary | 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. | Annual percentage of patients taking at least two treatments for their central hypersomnia. | ClinicalTrials.gov |
| Secondary | Number of diagnoses made between 2005 and 2023 that were modified by the new ICSD criteria in 2023. | During first analyses | Number of diagnoses made between 2005 and 2023 that were modified by the new ICSD criteria in 2023. | ClinicalTrials.gov |
| Secondary | Percentage 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. | ClinicalTrials.gov |
| Secondary | 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. | Number of patients with an initial diagnosis of NT2 who were reclassified as NT1 due to the onset of cataplexy. | ClinicalTrials.gov |
| Secondary | 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. | Percentage of patients with an initial diagnosis of NT2 who were reclassified as NT1 due to the onset of cataplexy. | ClinicalTrials.gov |
| Secondary | Epworth scale | 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. | ClinicalTrials.gov |
| Secondary | Wakefulness maintenance tests | 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. | ClinicalTrials.gov |
| Secondary | 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 age of these patients at the onset of cataplexy | ClinicalTrials.gov |
| Secondary | 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 initial diagnosis and onset of cataplexy | ClinicalTrials.gov |
| Secondary | 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. | Average number of years between first symptoms and onset of cataplexy. | ClinicalTrials.gov |
| Secondary | 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. | Adverse events collected during medical consultations | ClinicalTrials.gov |
| Secondary | Effects on other components of the pathologies | 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.). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.