Sleep Disorders in Patients With Multiple Sclerosis | NCT00137904

Studies
Sleep Disorders in Patients With Multiple Sclerosis

NCT00137904

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Status

Unknown status

Last Update Posted

Feb 9, 2006Estimated

Enrollment

Phase

Not provided

Conditions

Multiple Sclerosis

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

Aug 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 29, 2005

First Posted Date

Aug 30, 2005Estimated

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

Feb 8, 2006

Last Update Posted Date

Feb 9, 2006Estimated

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Description Module

Brief Summary

Fatigue is a frequent and disabling symptom in patients with multiple sclerosis (MS). The pathophysiology of this sign is not fully understood. Some data suggest that the fatigue is associated with sleep disorders. The aim of this study is to determine the polysomnographic parameters in MS patients with fatigue in comparison to MS patients without fatigue.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with multiple sclerosis
Expanded Disability Status Scale score < or = 5
Fatigue (Modified Fatigue Impact Scale > 45), with a disease duration > 3 months

Exclusion Criteria:

Depression
Cognitive disorders
EDSS > 5
Epilepsia
Obesity
Drug inducing sleep disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bruno Stankoff, MD, PhD	Contact	33-142161950		bruno.stankoff@psl.aphp.fr

Overall Officials

Name	Affiliation	Role
Bruno Stankoff, MD, PhD	CIC-Pitié-Salpêtrière	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre d'Investigation Clinique-Hopital Pitié-Salpêtrière	Recruiting	Paris		75013	France

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D005221	Fatigue
D012893	Sleep Wake Disorders

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided