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Sleep Disorders in Patients With Multiple Sclerosis

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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

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 Type : Observational
Enrollment : 51 participants
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

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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

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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

ClinicalTrials.gov Identifier: NCT00137904     History of Changes
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:
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