NCT05778721

Brief Summary

This is a study of only patients with idiopathic hypersomnia. It is a rare and still poorly understood pathology. In clinical practice, we have found that the treatment and care offered were not always effective. The idea of this study to improve knowledge of this pathology by studying the demographic characteristics of patients and other co-morbidities, in particular psychiatric patients, to see if we can identify common factor to our patients and useful in their medical care. The main objective of this research is to allow a quantitative study of the demographic and psychiatric characteristics of patients with idiopathic hypersomnia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 16, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2024

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

August 18, 2022

Last Update Submit

July 21, 2023

Conditions

Keywords

demographic characteristicpsychiatric morbidity

Outcome Measures

Primary Outcomes (2)

  • demographic characteristics

    SPAQ questionnaires

    day 1

  • psychiatric characteristics

    SACHS bipolarity index

    day 1

Study Arms (1)

adult patients with a diagnosis of idiopathic hypersomnia

adult patients with a diagnosis of idiopathic hypersomnia according to the International Classification of Sleep Disorders (ICSD 3) criteria and the performance of a 48-hour polysomnography at the Sleep Laboratory, between 2004 and today.

Other: respond to questionnaires by telephone

Interventions

Seasonal Pattern Assessment Questionnaire (SPAQ) questionnaires and Sachs bipolarity index and Idiopathic Hypersomnia (IH) severity score

adult patients with a diagnosis of idiopathic hypersomnia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with idiopathic hypersomnia

You may qualify if:

  • adult patients with a diagnosis of idiopathic hypersomnia according to the ICSD 3 criteria and the performance of a 48-hour polysomnography at the Sleep Laboratory, between 2004 and today.

You may not qualify if:

  • minors persons and under legal protection persons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Toulouse

Toulouse, 31000, France

RECRUITING

MeSH Terms

Conditions

Idiopathic HypersomniaMood DisordersBipolar Disorder

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBipolar and Related Disorders

Study Officials

  • Rachel DEBS, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2022

First Posted

March 21, 2023

Study Start

December 16, 2022

Primary Completion

June 16, 2024

Study Completion

June 16, 2024

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations