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

NCT ID: NCT03459300

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-01-17

Brief Summary

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

Detailed Description

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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

Conditions

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Hypersomnia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Antonia QUERA SALVA, MDPhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Hôpital raymond Poincaré

Garches, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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16047

Identifier Type: -

Identifier Source: org_study_id

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