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

Hypersomnia Clinical Trial

— Actisom  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459300
• Other study ID #: 16047
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: January 17, 2020

Study information

• Verified date: January 2021
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 17, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Hypersomnia
• Sleep Deprivation

Locations

Country	Name	City	State
France	Hôpital raymond Poincaré	Garches	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean total sleep time	mean total sleep time as measured by actimetry durind the 7 - 14 days before hospitalisation	7-14 days before hospitalisation