Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-11 @ 6:17 AM
Study NCT ID:
NCT03202602
Status:
COMPLETED
Last Update Posted:
2024-01-26
First Post:
2017-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefits of Telemedicine in CPAP Treatment
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2017-05-12', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CPAP adherence', 'timeFrame': '6 months', 'description': 'Time of CPAP use at follow-up. Assesed from count in CPAP machine.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction regarding CPAP treatment and contact with clinic', 'timeFrame': '6 months', 'description': 'Patient satisfaction regarding CPAP treatment and contact with clinic. Assessed via questionnaire.'}, {'measure': 'Number of visits/contacts.', 'timeFrame': '6 months', 'description': 'Number of visits/contacts. Assessed via hospital computer records.'}, {'measure': 'Duration of visits/contacts.', 'timeFrame': '6 months', 'description': 'Time duration of visits/contacs. Assessed via hospital computer records.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstructive sleep apnea', 'Continuous positive airway pressure', 'Telemoedicine'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '37337981', 'type': 'RESULT', 'citation': 'Ssegonja R, Ljunggren M, Sampaio F, Tegelmo T, Theorell-Haglow J. Economic evaluation of telemonitoring as a follow-up approach for patients with obstructive sleep apnea syndrome starting treatment with continuous positive airway pressure. J Sleep Res. 2024 May;33(3):e13968. doi: 10.1111/jsr.13968. Epub 2023 Jun 20.'}, {'pmid': '37323036', 'type': 'RESULT', 'citation': 'Delijaj F, Lindberg E, Johnsson L, Kristiansson P, Tegelmo T, Theorell-Haglow J. Effects of telemonitoring follow-up, side effects, and other factors on CPAP adherence. J Clin Sleep Med. 2023 Oct 1;19(10):1785-1795. doi: 10.5664/jcsm.10686.'}]}, 'descriptionModule': {'briefSummary': 'Continuous positive airway pressure (CPAP) is the first choice of treatment for moderate to severe obstructive sleep apnea syndrome (OSAS). Although adherence is critical for achieving a good treatment effect, and early intervention if treatment problems emerge is important for achieving good adherence, information on patient compliance is usually based on assessment of the first few weeks of treatment. Telemedicine technology allows for monitoring of CPAP pressure, air leaks, apnea-hypopnea index (AHI) and compliance on a daily basis and could therefore be an option allowing for adequate support and quick response if a patient has problems with the treatment. In addition, improving early experiences of CPAP, identifying patients in need of more intensive support could potentially improve adherence but also reduced cost of care, and increased patient satisfaction.\n\nThe proposed study will recruit 200 OSAS patients starting CPAP treatment; 100 patients randomized to afterwards receiving telemonitoring in combination with telephone calls, and 100 patients randomized to receiving usual office visits. All patients will in addition answer questionnaires on sleep and health, quality of life, and patient satisfaction after the first CPAP information visit and then again after 6 months of treatment. At time of follow-up all patients will also answer questionnaires on side effects of CPAP. Health economic variables will also be measured throughout the testing period.\n\nThe study will provide valuable information regarding benefits of telemonitoring in clinical work with CPAP therapy. Implementation of telemedicine-based monitoring of CPAP therapy may be an important part of increasing adherence among patients but also in the development of a more cost-effective care as it can provide clinics with increased treatment capacity and follow-up of both new and established patients. It would further improve the care for these patients who often have a lifelong treatment, which aims to reduce the risk of developing cardiovascular disease or premature death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diagnosed obstructive sleep apnea syndrome (OSAS) scheduled to receive continuous positive airway pressure (CPAP).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with OSA and scheduled to receive CPAP treatment\n\nExclusion Criteria:\n\n* Patients not understandning Swedish\n* Patients not eligible for CPAP start within a group session.'}, 'identificationModule': {'nctId': 'NCT03202602', 'briefTitle': 'Benefits of Telemedicine in CPAP Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'The Benefits of Telemedicine in CPAP Treatment of Obstructive Sleep Apnea Syndrome (OSAS)', 'orgStudyIdInfo': {'id': 'TelemedCPAP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Telemedicine', 'description': 'Patients randomized to receive telemonitoring in combination with telephone calls after CPAP start.', 'interventionNames': ['Other: Telemonitoring of CPAP treatment']}, {'label': 'Standard care', 'description': 'Patients randomized to receive usual office visits after CPAP start.', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'Telemonitoring of CPAP treatment', 'type': 'OTHER', 'description': 'Telemedicine technology allows for monitoring of CPAP pressure, air leaks, apnea-hypopnea index (AHI) and compliance on a daily basis.', 'armGroupLabels': ['Telemedicine']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Office visits and monitoring of CPAP treatment at each visit.', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Jenny Theorell-Haglöw, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jenny Theorell-Haglöw', 'investigatorAffiliation': 'Uppsala University'}}}}