Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-02-25 @ 2:34 AM
Study NCT ID:
NCT02740569
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2016-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples for metabolic and cardiovascular markers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-06', 'studyFirstSubmitDate': '2016-04-06', 'studyFirstSubmitQcDate': '2016-04-14', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of OSA defined by apnea-hypopnea index (AHI) of at least 15/h on the overnight sleep study', 'timeFrame': '6 months', 'description': 'All participants will be evaluated within 6 months'}], 'secondaryOutcomes': [{'measure': 'Occurrence of pulmonary involvement based on computer tomography findings', 'timeFrame': '6 months', 'description': 'All patients will be evaluated within 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['scleroderma', 'sleep apnea', 'pulmonary disease'], 'conditions': ['Scleroderma, Systemic', 'Sleep Apnea, Obstructive', 'Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '32285251', 'type': 'DERIVED', 'citation': 'Yakut T, Balcan B, Karakurt S, Direskeneli H, Yalcinkaya Y, Peker Y. Impact of concomitant obstructive sleep apnea on pulmonary involvement and main pulmonary artery diameter in adults with scleroderma. Sleep Breath. 2021 Mar;25(1):135-143. doi: 10.1007/s11325-020-02059-4. Epub 2020 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known regarding the prevalence of OSA in scleroderma and its association with pulmonary involvement.', 'detailedDescription': 'Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. OSA may also be seen in scleroderma. Less is known regarding the prevalence of obstructive sleep apnea in scleroderma and its association with pulmonary involvement.\n\nThe investigators would like to address the prevalence of OSA in patients with Scleroderma, using overnight cardiorespiratory polygraphy. Other comorbidities and pulmonary findings on computer tomography (CT) as well as lung function tests will be evaluated.\n\nThe investigators plan to include 60 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with known Scleroderma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known scleroderma diagnosis\n* Must be able to give informed consent\n\nExclusion Criteria:\n\n* Serious neurological and/or psychiatric disease'}, 'identificationModule': {'nctId': 'NCT02740569', 'acronym': 'OSASPI', 'briefTitle': 'Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement', 'orgStudyIdInfo': {'id': '09.2016.208'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Observational study. Intervention according to the clinical routines (not included in this part)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Pendik', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Yuksel Peker, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marmara University Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}