Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-02-20 @ 12:47 PM
Study NCT ID:
NCT00137904
Status:
UNKNOWN
Last Update Posted:
2006-02-09
First Post:
2005-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Disorders in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'count': 51}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'lastUpdateSubmitDate': '2006-02-08', 'studyFirstSubmitDate': '2005-08-29', 'studyFirstSubmitQcDate': '2005-08-29', 'lastUpdatePostDateStruct': {'date': '2006-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'fatigue', 'sleep disorders'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with multiple sclerosis\n* Expanded Disability Status Scale score \\< or = 5\n* Fatigue (Modified Fatigue Impact Scale \\> 45), with a disease duration \\> 3 months\n\nExclusion Criteria:\n\n* Depression\n* Cognitive disorders\n* EDSS \\> 5\n* Epilepsia\n* Obesity\n* Drug inducing sleep disorders'}, 'identificationModule': {'nctId': 'NCT00137904', 'briefTitle': 'Sleep Disorders in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Pitie-Salpetriere'}, 'officialTitle': 'Study of Sleep Disorders and Fatigue in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'RBM0242'}}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Laure Welter, MD', 'role': 'CONTACT', 'email': 'marie-laure.welter@psl.aphp.fr', 'phone': '33-42161950'}, {'name': 'Bruno Stankoff, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Centre d'Investigation Clinique-Hopital Pitié-Salpêtrière", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Bruno Stankoff, MD, PhD', 'role': 'CONTACT', 'email': 'bruno.stankoff@psl.aphp.fr', 'phone': '33-142161950'}], 'overallOfficials': [{'name': 'Bruno Stankoff, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CIC-Pitié-Salpêtrière'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Pitie-Salpetriere', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}]}}}