HYPERSOMNPSY: Psychiatric Co-morbidities and Socio-demographic Characteristics in Patients With Idiopathic Hypersomnia

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT05778721
Collaborator
(none)
150
1
6
25.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: respond to questionnaires by telephone

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Psychiatric Co-morbidities (Seasonal Affective Disorder and Bipolar Disorder) and Socio-demographic Characteristics in Patients With Idiopathic Hypersomnia: Quantitative Study Following 48-hour Polysomnographic Recordings.
Actual Study Start Date :
Dec 16, 2022
Anticipated Primary Completion Date :
Jun 16, 2023
Anticipated Study Completion Date :
Jun 16, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. demographic characteristics [day 1]

    SPAQ questionnaires

  2. psychiatric characteristics [day 1]

    SACHS bipolarity index

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.
Exclusion Criteria:
  • minors persons and under legal protection persons.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Toulouse Toulouse France 31000

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Rachel DEBS, MD, CHU Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT05778721
Other Study ID Numbers:
  • RC31/22/0127
First Posted:
Mar 21, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2023