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Sleep Disorders in Patients With Multiple Sclerosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00137904
First Posted: August 30, 2005
Last Update Posted: February 9, 2006
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.
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
  Purpose
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
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Study of Sleep Disorders and Fatigue in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Pitie-Salpetriere:

Estimated Enrollment: 51
  Eligibility

Information from the National Library of Medicine

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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
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
Contact: Bruno Stankoff, MD, PhD 33-142161950 bruno.stankoff@psl.aphp.fr

Locations
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
Principal Investigator: Bruno Stankoff, MD, PhD CIC-Pitié-Salpêtrière
  More Information

ClinicalTrials.gov Identifier: NCT00137904     History of Changes
Other Study ID Numbers: RBM0242
First Submitted: August 29, 2005
First Posted: August 30, 2005
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:
Sclerosis
Multiple Sclerosis
Sleep Wake Disorders
Parasomnias
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders