Importance of Sleep Deprivation in Differential Diagnosis... | NCT03459300

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

NCT03459300

Sponsor

Centre d'Investigation Clinique et Technologique 805

Status

Completed

Last Update Posted

Jan 26, 2021Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Hypersomnia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Jan 17, 2020Actual

Completion Date

Jan 17, 2020Actual

First Submitted Date

Mar 2, 2018

First Submission Date that Met QC Criteria

Mar 2, 2018

First Posted Date

Mar 8, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2021

Last Update Posted Date

Jan 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with a sleepiness evoking a primary hypersomnia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Antonia QUERA SALVA, MDPhD	APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital raymond Poincaré		Garches	Île-de-France Region	92380	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006970	Disorders of Excessive Somnolence

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided