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OpenTrials
Completed

NCT Number: NCT03459300

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

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

Completed

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Key information

Conditions

Hypersomnia Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital raymond Poincaré

Garches, Île-de-France Region, 92380, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Registry information

Official study title

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

Acronym: Actisom

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2018
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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