NCT03459300

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

March 2, 2018

Last Update Submit

January 25, 2021

Conditions

Hypersomnia

Keywords

actimetry

Outcome Measures

Primary Outcomes (1)

  • mean total sleep time

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

    7-14 days before hospitalisation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with a sleepiness evoking a primary hypersomnia

You may qualify if:

  • Men or women aged \> 18 years
  • Patient with a sleepiness evoking a primary hypersomnia
  • Epworth sleepiness scale \> 10
  • Information note signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital raymond Poincaré

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

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Maria Antonia QUERA SALVA, MDPhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 8, 2018

Study Start

February 1, 2018

Primary Completion

January 17, 2020

Study Completion

January 17, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)