Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-28 @ 6:21 AM
Study NCT ID:
NCT03314558
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2017-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From COPD ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-16', 'studyFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2017-10-16', 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sleep efficiency', 'timeFrame': '3 +/- 2 months', 'description': 'sleep efficiency assessed by actigraphy'}], 'secondaryOutcomes': [{'measure': 'steps', 'timeFrame': '3 +/- 2 months', 'description': 'number of steps walked daily assessed by actigraphy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'pulmonary rehabilitation', 'insomnia', 'sleep quality', 'physical activity'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'The purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients.', 'detailedDescription': 'COPD patients suffer from bad sleep quality. About 27 -50% are suffering from insomnia, and respiratory related symptoms are also inducing sleep disturbances. Recently, a correlation between altered sleep quality and low activity levels have been shown in this population. In primary insomnia, it is well established that physical activity has a positive impact on sleep quality.\n\nThe purpose of our study is to assess the impact of pulmonary rehabilitation on objective sleep quality in COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients physically able to follow a pulmonary rehabilitation program', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients\n* able to walk and cycle\n\nExclusion Criteria:\n\n* Shift work\n* orthopedic diseases of limbs'}, 'identificationModule': {'nctId': 'NCT03314558', 'briefTitle': 'Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From COPD ?', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Has Pulmonary Rehabilitation a Positive Impact on Sleep Quality in Patients Suffering From Chronic Obstructive Pulmonary Disease?', 'orgStudyIdInfo': {'id': 'RR2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD patients following a pulmonary rehabilitation program', 'description': 'COPD patients following a pulmonary rehabilitation program', 'interventionNames': ['Other: pulmonary rehabilitation']}], 'interventions': [{'name': 'pulmonary rehabilitation', 'type': 'OTHER', 'description': 'a pulmonary rehabilitation program of 30 sessions, (3X1h/ week), will be followed by the COPD patients', 'armGroupLabels': ['COPD patients following a pulmonary rehabilitation program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHu Saint Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chef de Clinique', 'investigatorFullName': 'Marie Bruyneel', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Saint Pierre'}}}}