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

July 21, 2023 updated by: University Hospital, Toulouse

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulouse, France, 31000
        • Recruiting
        • CHU Toulouse
        • Contact:
        • Principal Investigator:
          • Rachel DEBS, PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with idiopathic hypersomnia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
demographic characteristics
Time Frame: day 1
SPAQ questionnaires
day 1
psychiatric characteristics
Time Frame: day 1
SACHS bipolarity index
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Rachel DEBS, MD, CHU Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2022

Primary Completion (Estimated)

June 16, 2024

Study Completion (Estimated)

June 16, 2024

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/22/0127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Disorder

Clinical Trials on respond to questionnaires by telephone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe