Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia (Actisom dépistage) (Actisom)

January 25, 2021 updated by: Centre d'Investigation Clinique et Technologique 805

Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia in Reference Centers Rare Hypersomnia

7 to 14 days actimetry recording in order to exclude sleep deprivation just before hospitalisation for differential diagnosis of hypersomnia

Study Overview

Status

Completed

Conditions

Detailed Description

This is an observational study

Urine drug screening will also be performe

The suty includes four centers in France

The study duration is of one year

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

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

Study Locations

  • France
    • Ile De France
      • Garches, Ile De France, France, 92380
        • Hôpital Raymond Poincaré

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with a sleepiness evoking a primary hypersomnia

Description

Inclusion Criteria:

  • Men or women aged > 18 years
  • Patient with a sleepiness evoking a primary hypersomnia
  • Epworth sleepiness scale > 10
  • Information note signed

Exclusion Criteria:

  • Patient with type 1 or 2 narcolepsy and/or known hypersomnia
  • Frank cataplexy
  • Not stable metabolic, neurological or psychiatric disease
  • Patient treated by a medicine acting on the central nervous system
  • Patient having a shift work or having made a transmeridian flight of more than 3 hours lag in the previous month the research
  • Non affiliation to social security
  • Pregnancy
  • Patient under guardianship or curatorship

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean total sleep time
Time Frame: 7-14 days before hospitalisation
mean total sleep time as measured by actimetry durind the 7 - 14 days before hospitalisation
7-14 days before hospitalisation

Collaborators and Investigators

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

Sponsor

Centre d'Investigation Clinique et Technologique 805

Investigators

  • Principal Investigator: Maria Antonia QUERA SALVA, MDPhD, APHP

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)

February 1, 2018

Primary Completion (ACTUAL)

January 17, 2020

Study Completion (ACTUAL)

January 17, 2020

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 2, 2018

First Posted (ACTUAL)

March 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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