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CompletedNCT03459300ActisomUpdated Jan 26, 2021

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

An observational study in Hypersomnia, sponsored by Centre d'Investigation Clinique et Technologique 805. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-26.

Sponsored by Centre d'Investigation Clinique et Technologique 805 · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 30 studies in Disorders of Excessive Somnolence with a site in France — 9 open to participants now, 10 under way, 4 of them phase 3. Disorders of Excessive Somnolence · France.

Started
2018
the only one that year
Observational
6 of 30
1 open now
Registered
15th of 30
by date
Lead sponsor
1 of 30
Centre d'Investigation Clinique et Technologique 805

Among the 30 studies in Disorders of Excessive Somnolence with a site in France, this one is the only one that started in 2018, is one of 6 observational ones, and was the 15th registered.

Disorders of Excessive Somnolence

196 studies on the registry are indexed under Disorders of Excessive Somnolence; 34 are open to participants now.

Browse Disorders of Excessive Somnolence studies →

Open to participants now

9 of the 30 studies in Disorders of Excessive Somnolence with a site in France are open now. Recruiting first, the newest first:

4 more — sign in →

All 9 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 30 Disorders of Excessive Somnolence studies recruiting now, 12 (40%) set no upper age limit and 17 (57%) stop at 75 or younger; 5 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

Read the 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

03

Conditions studied

  • Hypersomnia

Keywords

  • actimetry
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with a sleepiness evoking a primary hypersomnia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. mean total sleep time

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

    Time frame: 7-14 days before hospitalisation

07

Study locations

1 site
  • Hôpital raymond Poincaré
    Garches, Ile De France 92380, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Jan 2020, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2018
First posted
Mar 8, 2018
StartActual
Feb 1, 2018
Primary completionActual
Jan 17, 2020
CompletionActual
Jan 17, 2020
Last update
Jan 26, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03459300
Lead sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible party
Sponsor
First posted
Mar 8, 2018
Start date
Feb 1, 2018
Primary completion
Jan 17, 2020
Completion
Jan 17, 2020
Last update
Jan 26, 2021

Study contacts

Maria Antonia QUERA SALVA, MDPhD
principal investigator · APHP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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