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Sleep Disorders in Patients With Multiple Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT00137904
First received: August 29, 2005
Last updated: February 8, 2006
Last verified: August 2005
History of Changes
  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:

U.S. FDA Resources

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

Estimated Enrollment: 51
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00137904     History of Changes
Other Study ID Numbers: RBM0242
Study First Received: August 29, 2005
Last Updated: February 8, 2006
Health Authority: France: Ministry of Health

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
multiple sclerosis
fatigue
sleep disorders

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Sleep Disorders
Parasomnias
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013