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NCT05778721 Clinical Trial

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

Bipolar Disorder Clinical Trial

— HYPERSOMNPSY  

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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05778721
Other study ID # RC31/22/0127
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 16, 2022
Est. completion date June 16, 2024

Study information
Verified date July 2023
Source University Hospital, Toulouse
Contact Rachel DEBS, MD
Phone 05 61 77 94 88
Email debs.r@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date June 16, 2024
Est. primary completion date June 16, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• respond to questionnaires by telephone
Seasonal Pattern Assessment Questionnaire (SPAQ) questionnaires and Sachs bipolarity index and Idiopathic Hypersomnia (IH) severity score

Locations
Country Name City State
France Chu Toulouse Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary demographic characteristics SPAQ questionnaires day 1
Primary psychiatric characteristics SACHS bipolarity index day 1
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