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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03459300
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

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

Condition or disease
Hypersomnia

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

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia in Reference Centers Rare Hypersomnia
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : January 17, 2020
Actual Study Completion Date : January 17, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with a sleepiness evoking a primary hypersomnia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459300


Locations
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France
Hôpital raymond Poincaré
Garches, Ile De France, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
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Principal Investigator: Maria Antonia QUERA SALVA, MDPhD APHP
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Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT03459300    
Other Study ID Numbers: 16047
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre d'Investigation Clinique et Technologique 805:
actimetry
Additional relevant MeSH terms:
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Sleep Deprivation
Disorders of Excessive Somnolence
Idiopathic Hypersomnia
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Sleep Disorders, Intrinsic