Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT05894733
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2023-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Frequent Follow up on Compliance in Patients Receiving PAP Therapy Due to OSA (Pap: Positive Airway Pressure, OSA: Obstructive Sleep Apnea )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2023-06-07', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'follow-up', 'timeFrame': '1 year', 'description': 'Short-term compliance( mean duration time to use CPAP therapy) was measured during the first follow-up, and long-term compliance was measured during the last follow-up.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Compliance', 'Sleep Disorder', 'Obstructive Sleep Apnea of Adult']}, 'descriptionModule': {'briefSummary': "The investigators planned to investigate the effect of close monitoring on compliance and the factors affecting compliance among patients receiving PAP treatment due to OSA.This study was a single-center, prospective, randomized, controlled study approved by the hospital's ethics committee.One hundred twenty-eight patients were randomized as group one or two as group 1 is the study and group 2 is the control group. The first group was called by phone on the 15th day to ask if there were any complaints or problems with the device. Sequentially, they were called for controls at the end of the first, third, and sixth months.\n\nThe second group was accepted as the control group, following our clinic's standard procedure in the first and sixth months. The patients who came to the control were asked if there were any problems with the device and any difficulties in use, and they were again informed about the devices and masks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:, .newly diagnosed OSA with PSG , and underwent PAP titration\n\nExclusion Criteria:\n\n. unfollowed patients'}, 'identificationModule': {'nctId': 'NCT05894733', 'briefTitle': 'The Effects of Frequent Follow up on Compliance in Patients Receiving PAP Therapy Due to OSA (Pap: Positive Airway Pressure, OSA: Obstructive Sleep Apnea )', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital'}, 'officialTitle': 'The Effects of Frequent Follow up on Compliance in Patients Receiving PAP Therapy Due to OSA', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': '1: The first group was called by phone on the 15th day to ask if there were any complaints or problems with the device. Sequentially, they were called for controls at the end of the first, third, and sixth months.', 'interventionNames': ['Other: study group']}, {'type': 'OTHER', 'label': '2', 'description': "2:The second group was accepted as the control group, following our clinic's standard procedure in the first and sixth months", 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'study group', 'type': 'OTHER', 'description': 'Calling with phone frequently(15.th day, 1 month , 3 month, 6 month ) and face to face interwiew on first, 3 th and 6th month', 'armGroupLabels': ['1']}, {'name': 'control group', 'type': 'OTHER', 'description': 'first and sixth month face to face interwiew', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maltepe', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Makbule Özlem', 'geoPoint': {'lat': 40.93567, 'lon': 29.15507}}], 'overallOfficials': [{'name': 'makbule özlem akbay, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'sureyyapasa chest diseases center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'Makbule Özlem Akbay', 'investigatorAffiliation': 'Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital'}}}}