Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT01642160
Status:
COMPLETED
Last Update Posted:
2013-03-07
First Post:
2012-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continous Positive Airway Pressure (CPAP) Compliance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-05', 'studyFirstSubmitDate': '2012-07-13', 'studyFirstSubmitQcDate': '2012-07-16', 'lastUpdatePostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in mean number of nursing interventions at one month', 'timeFrame': 'baseline to one month after initiation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea (OSA)']}, 'descriptionModule': {'briefSummary': 'Does an internet based text or email interaction and education improve CPAP compliance for patients with Obstructive sleep apnea (OSA) and reduce nursing intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age 18 - 90 years of age) newly diagnosed with OSA who have been recommended CPAP therapy.\n\nExclusion Criteria:\n\n* Previously attempted CPAP, requires the use of bilevel positive airway pressure device, difficulty with English language such that they have difficulty understanding instructions given at high school equivalent, periodic limb movement associated arousals greater than 20/hour, primary complaint of insomnia, diagnosis of restless leg syndrome or periodic limb movement disorder'}, 'identificationModule': {'nctId': 'NCT01642160', 'acronym': 'ICAN', 'briefTitle': 'Continous Positive Airway Pressure (CPAP) Compliance Study', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'ICAN (Improvement in CPAP Adherence Via the Net) Study', 'orgStudyIdInfo': {'id': '11-008195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'Participants randomized to this arm will have the usual follow up care without any additional information.', 'interventionNames': ['Behavioral: Standard of care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Additional Education', 'description': 'This arm will receive a weekly text message or e-mail asking participants to sign on to the web page that we will provide. Once they sign on, they will see additional educational materials and questions regarding their CPAP use. Based on their response, they will be directed to suggestion or sites to help improve their compliance with their CPAP.', 'interventionNames': ['Behavioral: additional educational material']}], 'interventions': [{'name': 'additional educational material', 'type': 'BEHAVIORAL', 'description': "The internet-based intervention group would receive a weekly text or an email (based on the subject's preference). The content of the message asks about their approximate compliance over the past week. Based on their response, they will be directed to one of two internet web pages.", 'armGroupLabels': ['Additional Education']}, {'name': 'Standard of care', 'type': 'BEHAVIORAL', 'description': 'participants will receive education from staff nurses as needed.', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'John Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'John G. Park', 'investigatorAffiliation': 'Mayo Clinic'}}}}