Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep Disorders in Patients With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137904
Recruitment Status : Unknown
Verified August 2005 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was:  Recruiting
First Posted : August 30, 2005
Last Update Posted : February 9, 2006
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Groupe Hospitalier Pitie-Salpetriere

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Multiple Sclerosis

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Enrollment : 51 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Study of Sleep Disorders and Fatigue in Patients With Multiple Sclerosis

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137904


Contacts
Layout table for location contacts
Contact: Bruno Stankoff, MD, PhD 33-142161950 bruno.stankoff@psl.aphp.fr

Locations
Layout table for location information
France
Centre d'Investigation Clinique-Hopital Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Marie-Laure Welter, MD    33-42161950    marie-laure.welter@psl.aphp.fr   
Principal Investigator: Bruno Stankoff, MD, PhD         
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Layout table for investigator information
Principal Investigator: Bruno Stankoff, MD, PhD CIC-Pitié-Salpêtrière
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00137904    
Other Study ID Numbers: RBM0242
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: February 9, 2006
Last Verified: August 2005
Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
multiple sclerosis
fatigue
sleep disorders
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sleep Wake Disorders
Parasomnias
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Mental Disorders