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

NCT03459300 — Completed, 100 participants, Centre d'Investigation Clinique et Technologique 805

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

RegistryNCT03459300, acronym Actisom
StatusCompleted
Study typeObservational
Enrollment100 (Actual)
SponsorCentre d'Investigation Clinique et Technologique 805 (Other)
ConditionsHypersomnia
Datesstart 2018-02-01, primary completion 2020-01-17, completion 2020-01-17, first posted 2018-03-08, last updated 2021-01-26
Locations1 site in France

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-Summary

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

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+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

+Outcome measures

Primary outcomes

  • mean total sleep time [7-14 days before hospitalisation]: mean total sleep time as measured by actimetry durind the 7 - 14 days before hospitalisation

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Hôpital raymond PoincaréGarches, Île-de-France RegionFrance

+Investigators

  • Maria Antonia QUERA SALVA, MDPhD, Principal investigator, APHP