Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-03-05 @ 6:58 PM
Study NCT ID:
NCT03908905
Status:
SUSPENDED
Last Update Posted:
2024-02-29
First Post:
2019-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Disturbances and Chronic Widespread Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017286', 'term': 'Polysomnography'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Lack of resources', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Polysomnography', 'timeFrame': '6 months', 'description': 'Assessment of objective sleep problems'}], 'secondaryOutcomes': [{'measure': 'CANTAB', 'timeFrame': '6 months', 'description': 'Neurocognitive screening'}, {'measure': 'Actigraph', 'timeFrame': '6 months', 'description': 'Activity level'}, {'measure': 'Biomarkers', 'timeFrame': '6 months', 'description': '92-plex inflammatory panel'}, {'measure': 'Pain level', 'timeFrame': '6 months', 'description': "The Brief Pain Inventory - Short Form, BPI, a 9 item (0-10) self-administered questionnaire, assessing the severity of a patient's pain and the impact of this pain on the patient's daily functioning. Maximum total score possible is 90. Higher the score, greater the degree of disability."}, {'measure': 'Fatigue', 'timeFrame': '6 months', 'description': 'Fatigue severity scale, FSS, a 9 item self-administered questionnaire assessing severity of fatigue and how fatigue interferes with activity. Items are scored on a 7 point scale, minimum total score possible is 9 and maximum 63. Higher the score, greater the severity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Sleep', 'Neuropsychology', 'Fatigue', 'Activity level', 'Attention', 'Executive function', 'Memory'], 'conditions': ['Chronic Widespread Pain', 'Sleep Disturbance']}, 'descriptionModule': {'briefSummary': 'Chronic widespread pain (CWP), defined as long-lasting pain in multiple body regions, has a prevalence of 10-14% in Europe and is associated with other physical symptoms such as fatigue and cognitive problems. Individuals with longstanding pain also have a high prevalence of sleep disturbances, and sleep problems can in itself lead to tiredness, lower neurocognitive function and higher pain ratings. However, studies of comorbid sleep problems for individuals with CWP are a lacking, and the primary aim for the present study is to assess the prevalence of sleep disturbances in individuals with CWP, and to see how this covariates with pain, fatigue, activity level, neurocognitive functioning, and biomarkers. As a secondary aim the study will assess a subgroup of the individuals, that has received multimodal pain management treatment, a second time after 6 months to analyze how the prevalence of sleep disturbances and other associated problems covaries over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects that are referred for an inpatient multidisciplinary analysis of complex chronic pain conditions at a regional pain center at Uppsala University Hospital.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Widespread Pain\n\nExclusion Criteria:\n\n* Other untreated and or serious psychiatric or somatic conditions'}, 'identificationModule': {'nctId': 'NCT03908905', 'acronym': 'POSEIDON', 'briefTitle': 'Sleep Disturbances and Chronic Widespread Pain', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Prevalence of Sleep Disturbances in Individuals With Chronic Widespread Pain', 'orgStudyIdInfo': {'id': '2019-00018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention', 'interventionNames': ['Diagnostic Test: Polysomnography']}], 'interventions': [{'name': 'Polysomnography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Sleep screening, neurocognitive assessment, activity monitoring questionnaires, blood sample', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '752 60', 'city': 'Uppsala', 'state': 'Uppsala County', 'country': 'Sweden', 'facility': 'Uppsala university hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}