Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-01-04 @ 6:56 PM
Study NCT ID:
NCT01715194
Status:
COMPLETED
Last Update Posted:
2016-07-26
First Post:
2012-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedicine to Enhance Adherence to CPAP Therapy in Patients With OSAS
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2012-10-10', 'studyFirstSubmitQcDate': '2012-10-24', 'lastUpdatePostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of nights with efficient CPAP use (defined as ≥4h of CPAP use per night within the last month including nights of no-use of CPAP) at 6 months', 'timeFrame': 'at 6 months'}, {'measure': 'Average nightly use of CPAP during the first 6 months of treatment (minutes per night excluding nights of no-use of CPAP)', 'timeFrame': 'at 6 months'}, {'measure': 'Proportion of CPAP users (defined as ≥1h of CPAP use per night within the last week) at 1 month', 'timeFrame': 'at 1 month'}, {'measure': 'Average nightly use of CPAP during the first month of treatment (minutes per night including nights of no-use of CPAP since day 1)', 'timeFrame': 'at 1 month'}, {'measure': 'Proportion of efficient CPAP users (defined as ≥4h of CPAP use per night within the last week including nights of no-use of CPAP) at 1 month', 'timeFrame': 'at 1 month'}, {'measure': 'Average nightly use of CPAP during the first month of treatment (minutes per night excluding nights of no-use of CPAP)', 'timeFrame': 'at 1 month'}, {'measure': 'Mask leakage at 1 and 6 months', 'timeFrame': 'at 1 and 6 months'}, {'measure': 'Adverse effects on CPAP at 1 and 6 months', 'timeFrame': 'at 1 and 6 months', 'description': 'The proportion of patients with insomnia/dyssomnia due to CPAP, skin problems due to the mask, oronasal dryness or other treatment related complaints is assessed.'}, {'measure': 'Patient satisfaction (measured with a specifically designed short questionnaire and on a visual analogue scale (VAS)) at 1 and 6 months', 'timeFrame': 'at 1 and 6 months'}, {'measure': 'Likelihood of discontinuing CPAP is estimated with Kaplan Meyer analysis and groups are compared with the Cox proportional hazard ratio analysis.', 'timeFrame': 'at 6 months'}, {'measure': 'Cardiovascular risk factors in serum (e.g. cholesterol, C-peptid, ...), blood pressure and night time assessment of sleep quality with the novel assessment tool "SOMNOcheck micro".', 'timeFrame': 'at 1 and 6 months'}], 'primaryOutcomes': [{'measure': 'Proportion of nights with CPAP use (defined as ≥1h of CPAP use per night within the last month including nights of no-use of CPAP) at 6 months', 'timeFrame': 'at 6 months'}], 'secondaryOutcomes': [{'measure': 'Average nightly use of CPAP during the first 6 months of treatment (minutes per night including nights of no-use of CPAP since day 1)', 'timeFrame': 'at 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OSAS', 'CPAP', 'Adherence', 'Telemedicine'], 'conditions': ['Obstructive Sleep Apnea Syndrome']}, 'referencesModule': {'references': [{'pmid': '20880872', 'type': 'BACKGROUND', 'citation': 'Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29.'}, {'pmid': '15319046', 'type': 'BACKGROUND', 'citation': 'Lankford DA. Wireless CPAP patient monitoring: accuracy study. Telemed J E Health. 2004 Summer;10(2):162-9. doi: 10.1089/tmj.2004.10.162.'}, {'pmid': '16796496', 'type': 'BACKGROUND', 'citation': 'Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, Leeds W. Telehealth services to improve nonadherence: A placebo-controlled study. Telemed J E Health. 2006 Jun;12(3):289-96. doi: 10.1089/tmj.2006.12.289.'}, {'pmid': '17513285', 'type': 'BACKGROUND', 'citation': 'Stepnowsky CJ, Palau JJ, Marler MR, Gifford AL. Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea. J Med Internet Res. 2007 May 17;9(2):e14. doi: 10.2196/jmir.9.2.e14.'}, {'pmid': '20978030', 'type': 'BACKGROUND', 'citation': 'Kwiatkowska M, Ayas N. Can telemedicine improve CPAP adherence? Thorax. 2010 Dec;65(12):1035-6. doi: 10.1136/thx.2010.140897. Epub 2010 Oct 26. No abstract available.'}, {'pmid': '31310575', 'type': 'DERIVED', 'citation': 'Schoch OD, Baty F, Boesch M, Benz G, Niedermann J, Brutsche MH. Telemedicine for Continuous Positive Airway Pressure in Sleep Apnea. A Randomized, Controlled Study. Ann Am Thorac Soc. 2019 Dec;16(12):1550-1557. doi: 10.1513/AnnalsATS.201901-013OC.'}]}, 'descriptionModule': {'briefSummary': 'We hypothesize that the use of telemedicine combined with support interventions by short messages, telephone calls and ambulatory visits to control CPAP treatment during the first month improves adherence and reduces unresolved side effects of therapy.\n\nThe primary objective of an OSAS treatment program is to successfully implement indicated CPAP in the highest possible proportion of patients in order to lower the proportion of untreated OSAS in the population. On an individual basis, it has been shown that a longer duration of CPAP use is associated with better outcomes in terms of daytime functioning and in the control of metabolic and blood pressure effects of CPAP. For our study, we have therefore decided to use 2 co-primary endpoints, taking into account both aspects of adherence mentioned. Cardiovascular complications are a major concern in OSAS patients. Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk. We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic OSAS patients with an AHI and an oxygen desaturation index (ODI) of \\>5/h in polysomnography (PSG) consenting to start longterm CPAP treatment.\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Unable to communicate in German, English, French or Italian\n* Alcohol consumption \\> 4 units \\>4 times a week\n* Acute manifestation of psychiatric diseases\n* Life expectancy of \\< 6 months for any reason\n* Surgical obesity treatment planned within the next 6 months\n* Predominantly Central sleep apnea and cheyne stokes respiration'}, 'identificationModule': {'nctId': 'NCT01715194', 'briefTitle': 'Telemedicine to Enhance Adherence to CPAP Therapy in Patients With OSAS', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital of St. Gallen'}, 'officialTitle': 'Telemedicine to Enhance Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome; a Randomized Placebo-controlled Prospective Study', 'orgStudyIdInfo': {'id': 'EKSG 12/076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Telemedicine intervention', 'description': 'In the telemedicine intervention arm, a telemetry device is instructed and attached to the CPAP. Patients are instructed to use CPAP every night. Data of the CPAP are downloaded to the internet once daily. On week days, a nurse is checking the downloaded data three times per week. The nurse contacts the patient if\n\n1. CPAP was used \\<4h/ night for 2 consecutive night\n2. the median leakage was above 0.4 L/sec on 2 consecutive nights The nurse informs the patient of the problem observed, asks for explanations and gives advice on possibilities to solve the problem. The common problems and the respective solutions are discussed according to the ELF facts sheet (Dry mouth/throat, nasal congestion, skin irritation, conjunctivitis, headache, loss of benefits, appendix 1). The patient is encouraged to use CPAP every night. In the case of regular use and acceptable leakage, a congratulatory message is sent to the patient via sms or e-mail (for procedural rules, see appendix 4).', 'interventionNames': ['Device: Telemedicine intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control (without telemedicine)', 'description': 'In the control arm, no device is attached to the CPAP machine, but data stored in the CPAP machine are collected at the follow-up visit after 1 month of CPAP use.'}], 'interventions': [{'name': 'Telemedicine intervention', 'type': 'DEVICE', 'otherNames': ['ResMed Telemedicine S9 Wireless-Modul'], 'description': 'Patients undergoing telemedicine intervention', 'armGroupLabels': ['Telemedicine intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9007', 'city': 'Sankt Gallen', 'state': 'CH', 'country': 'Switzerland', 'facility': 'Cantonal Hospital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'overallOfficials': [{'name': 'Martin Brutsche, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cantonal Hospital St. Gallen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otto D. Schoch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor investigator', 'investigatorFullName': 'Otto D. Schoch', 'investigatorAffiliation': 'Cantonal Hospital of St. Gallen'}}}}