Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03459300
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : June 28, 2018
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


Layout table for study information
Study Type : Observational
Estimated 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
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Contacts
Layout table for location contacts
Contact: Maria Antonia QUERA SALVA, MD PhD 0033 147104016 ma.quera@aphp.fr
Contact: Erica VLACHOS, CRA 0033 147104472 erica.vlachos@aphp.fr

Locations
Layout table for location information
France
Hôpital raymond Poincaré Recruiting
Garches, Ile De France, France, 92380
Contact: Maria Antonia QUERA SALVA, MD PhD    0033 147104016    ma.quera@aphp.fr   
Contact: Erica VLACHOS, CRA    0033 147104472    erica.vlachos@aphp.fr   
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
Layout table for investigator information
Principal Investigator: Maria Antonia QUERA SALVA, MDPhD APHP

Layout table for additonal information
Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT03459300     History of Changes
Other Study ID Numbers: 16047
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Sleep Deprivation
Disorders of Excessive Somnolence
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Sleep Disorders, Intrinsic