Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-11 @ 4:02 PM
Study NCT ID:
NCT02553694
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2014-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Apnea Video Education for CPAP (SAVE-CPAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D001049', 'term': 'Apnea'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-02', 'studyFirstSubmitDate': '2014-08-05', 'studyFirstSubmitQcDate': '2015-09-16', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CPAP Therapy Adherence', 'timeFrame': '30 days post in-lab split night polysomnogram', 'description': 'Subject use of CPAP device will be monitored electronically. Subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to in-laboratory split night polysomnogram (sleep study) and initiation of CPAP therapy, and CPAP adherence rates of the two groups will be compared and reported.'}], 'secondaryOutcomes': [{'measure': 'Subject compliance with sleep clinic appointment', 'timeFrame': 'within 3 months after the in-laboratory split night polysomnogram', 'description': 'Subjects will be randomized to receive a reminder call for follow up clinic appointment either from MD or staff, and the compliance rates of the two groups will be compared based on call type and educational intervention type.'}, {'measure': 'Patient Knowledge About Sleep Apnea and CPAP Therapy', 'timeFrame': '1 day post in-laboratory split night polysomnogram', 'description': 'Subjects will be administered 2 questionnaires which measure knowledge about their condition, both before and after the in-laboratory split night polysomnogram (sleep study). The scores of the two questionnaires will be combined for both test administrations. Subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to sleep study and initiation of CPAP therapy, and the change in the combined questionnaire scores of the two groups will be compared and reported.'}, {'measure': 'Patient Satisfaction With the in-laboratory split night polysomnogram', 'timeFrame': '1 day post in-laboratory split night polysomnogram', 'description': 'Subjects will be administered 2 questionnaires which measure their mood and well-being, both before and after the in-laboratory split night polysomnogram. The questionnaires will be scored and the scores for each subject will be combined at both testing administrations. On the night of the in-laboratory polysomnogram subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to the initiation of the polysomnogram and initiation of CPAP therapy, and the change in the combined questionnaire scores of the two groups will be compared and reported.'}, {'measure': 'CPAP Therapy Adherence', 'timeFrame': '1 month post sleep clinic visit or the date of the missed sleep clinic visit', 'description': 'Subjects will be randomized to receive a reminder call for follow up sleep clinic appointment either from MD or non-MD sleep center staff, and the compliance rates of the two groups will be compared based on call type and educational intervention type.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OSA, Apnea'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '21253882', 'type': 'BACKGROUND', 'citation': 'Kohli P, Balachandran JS, Malhotra A. Obstructive sleep apnea and the risk for cardiovascular disease. Curr Atheroscler Rep. 2011 Apr;13(2):138-46. doi: 10.1007/s11883-011-0161-8.'}, {'pmid': '22005190', 'type': 'BACKGROUND', 'citation': 'Metabolic disorders associated with obstructive sleep apnea in adults. Adv Cardiol. 2011;46:67-138. doi: 10.1159/000325106. Epub 2011 Oct 13.'}, {'pmid': '23493772', 'type': 'BACKGROUND', 'citation': "Balachandran JS, Yu X, Wroblewski K, Mokhlesi B. A brief survey of patients' first impression after CPAP titration predicts future CPAP adherence: a pilot study. J Clin Sleep Med. 2013 Mar 15;9(3):199-205. doi: 10.5664/jcsm.2476."}, {'pmid': '28667231', 'type': 'DERIVED', 'citation': 'Guralnick AS, Balachandran JS, Szutenbach S, Adley K, Emami L, Mohammadi M, Farnan JM, Arora VM, Mokhlesi B. Educational video to improve CPAP use in patients with obstructive sleep apnoea at risk for poor adherence: a randomised controlled trial. Thorax. 2017 Dec;72(12):1132-1139. doi: 10.1136/thoraxjnl-2017-210106. Epub 2017 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how satisfied patients are when undergoing an overnight polysomnogram (sleep study), what their knowledge about sleep apnea is, and what factors affect obstructive sleep apnea (OSA) treatment use.', 'detailedDescription': 'The effects of educational interventions on subject compliance, satisfaction, and knowledge of their condition will be examined through the use of video vs pamphlet and MD vs staff contact for follow-up visit reminder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged \\> 18 years of age who are referred to the University of Chicago sleep laboratory for split-night polysomnography by a non-sleep physician and who have a consultation appointment with a sleep physician following the appointment\n* Have not had prior contact with a sleep physician or prior exposure to CPAP therapy.\n\nExclusion Criteria: Subjects will be excluded for any of the following characteristics: -Non-English speaking\n\n* Illiterate\n* Sleep study is negative for sleep apnea (apnea-hypopnea index \\< 5 events/hr)\n* Subject does not undergo CPAP titration during the in-laboratory polysomnogram\n* Subject does not have a working telephone number\n* Poor eyesight or hearing\n* Dementia'}, 'identificationModule': {'nctId': 'NCT02553694', 'acronym': 'SAVE-CPAP', 'briefTitle': 'Sleep Apnea Video Education for CPAP (SAVE-CPAP)', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Impact of a Short Educational Video on OSA Patient Satisfaction, Knowledge and Outcomes', 'orgStudyIdInfo': {'id': 'IRB14-0198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced education and Enhanced follow up', 'description': 'Subjects will watch a short video and will be contacted by an MD by phone', 'interventionNames': ['Other: Enhanced education', 'Other: Usual follow up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual education and Usual follow up', 'description': 'Standard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and will be contacted by a sleep center staff member by phone', 'interventionNames': ['Other: Usual education', 'Other: Enhanced follow up']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced education and Usual follow up', 'description': 'Subjects will watch a short video immediately prior to the initiation of the in-laboratory polysomnogram and will be contacted by sleep center non-MD staff member by phone', 'interventionNames': ['Other: Enhanced education', 'Other: Enhanced follow up']}, {'type': 'EXPERIMENTAL', 'label': 'Usual education with Enhanced follow up', 'description': 'Standard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and contacted by an MD by phone', 'interventionNames': ['Other: Usual education', 'Other: Usual follow up']}], 'interventions': [{'name': 'Enhanced education', 'type': 'OTHER', 'description': 'Investigator created video to help educate subject before the in-laboratory split night polysomnogram. The subject will watch the short video immediately prior to the initiation of the in-laboratory polysomnogram.', 'armGroupLabels': ['Enhanced education and Enhanced follow up', 'Enhanced education and Usual follow up']}, {'name': 'Usual education', 'type': 'OTHER', 'description': 'Usual education by American Academy of Sleep Medicine (AASM)- created educational pamphlets', 'armGroupLabels': ['Usual education and Usual follow up', 'Usual education with Enhanced follow up']}, {'name': 'Usual follow up', 'type': 'OTHER', 'description': 'MD will follow up by phone after the in-laboratory split night polysomnogram', 'armGroupLabels': ['Enhanced education and Enhanced follow up', 'Usual education with Enhanced follow up']}, {'name': 'Enhanced follow up', 'type': 'OTHER', 'description': 'Sleep center non-MD staff member will follow up by phone after the in-laboratory split night polysomnogram', 'armGroupLabels': ['Enhanced education and Usual follow up', 'Usual education and Usual follow up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Babak Mokhlesi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}