NCT00137904

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
Last Updated

February 9, 2006

Status Verified

August 1, 2005

First QC Date

August 29, 2005

Last Update Submit

February 8, 2006

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisfatiguesleep disorders

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique-Hopital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Multiple SclerosisFatigueSleep Wake Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic ManifestationsMental Disorders

Study Officials

  • Bruno Stankoff, MD, PhD

    CIC-Pitié-Salpêtrière

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Stankoff, MD, PhD

CONTACT

33-142161950bruno.stankoff@psl.aphp.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Last Updated

February 9, 2006

Record last verified: 2005-08

Locations

FR(1)