Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT00482859
Status:
COMPLETED
Last Update Posted:
2009-01-22
First Post:
2007-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-21', 'studyFirstSubmitDate': '2007-06-03', 'studyFirstSubmitQcDate': '2007-06-04', 'lastUpdatePostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fibromyalgia Syndrome'], 'conditions': ['Fibromyalgia Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this week long study is to describe sleep and problems with sleep in women diagnosed with Fibromyalgia syndrome.', 'detailedDescription': 'At least 50 women over 18 years of age are invited to volunteer in this study. Sleep quality and problems with sleep will be described using several kinds of measures. Questionnaires on sleep and Fibromyalgia will be completed by the volunteer. In addition, the volunteer will complete a sleep diary for at least 7 days and wear an Actiwatch (a wrist watch like device that measures sleep). At completion of the study, participants will be provided a print out of their sleep obtained from the Actiwatch.\n\nParticipants may not be in the study if they work night shift (11 pm - 7 am) or have been diagnosed with a condition called sleep apnea.\n\nParticipants need not live in Kentucky to participate in this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with Fibromyalgia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18 years old; diagnosed with Fibromyalgia;\n\nExclusion Criteria:\n\n* Volunteer works night shift (11PM - 7AM);\n* Volunteer has been diagnosed with sleep apnea.'}, 'identificationModule': {'nctId': 'NCT00482859', 'briefTitle': 'Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome', 'orgStudyIdInfo': {'id': '07-0188-P2G'}, 'secondaryIdInfos': [{'id': 'Non-Applicable'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Suzette L Sewell, RN MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kentucky', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Suzette L. Sewell Scheuermann RN', 'oldOrganization': 'University of Kentucky College of Nursing'}}}}