Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-03-22 @ 6:12 AM
Study NCT ID:
NCT02553902
Status:
UNKNOWN
Last Update Posted:
2018-04-11
First Post:
2015-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017090', 'term': 'Occlusal Splints'}, {'id': 'D018810', 'term': 'Magnetic Resonance Angiography'}, {'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000792', 'term': 'Angiography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-10', 'studyFirstSubmitDate': '2015-09-14', 'studyFirstSubmitQcDate': '2015-09-17', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-hypopnea index (AHI)', 'timeFrame': 'change from baseline, after 3, 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Outcome of Quality of Life questionnaires', 'timeFrame': 'change from baseline, after 3, 6 and 12 months', 'description': 'EQ-5D'}, {'measure': 'Outcome of Quality of Life questionnaires', 'timeFrame': 'change from baseline, after 3, 6 and 12 months', 'description': 'Epworth Sleeping Scale (ESS)'}, {'measure': 'Outcome of Quality of Life questionnaires', 'timeFrame': 'change from baseline, after 3, 6 and 12 months', 'description': 'Functional Outcome Sleep Questionnaire (FOSQ)'}, {'measure': '(Societal) costs of treatment', 'timeFrame': 'change from baseline, after 3, 6 and 12 months', 'description': 'iMTA Productivity Cost Questionnaire (iPCQ)'}, {'measure': '(Societal) costs of treatment', 'timeFrame': 'change from baseline, after 3, 6 and 12 months', 'description': 'iMTA Medical Consumption Questionnaire (iMCQ)'}, {'measure': 'Therapy compliance', 'timeFrame': 'change from baseline, after 3, 6 and 12 months', 'description': 'Measurement of actual wearing time (in hours) per night'}, {'measure': 'Cardiovascular parameters', 'timeFrame': 'change from baseline, after 3, 6 and 12 months', 'description': 'Systolic and diastolic blood pressure'}, {'measure': 'Cardiovascular parameters', 'timeFrame': 'change from baseline, after 3, 6 and 12 months', 'description': 'Pulse rate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Positional therapy', 'MAD', 'Oral appliance', 'Sleep position trainer', 'POSA'], 'conditions': ['Positional Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'OBJECTIVES:\n\nTo evaluate the effect and cost-utility of a combination therapy of SPT+MAD compared with continuous positive airway pressure (CPAP) in patients with moderate positional obstructive sleep apnea (POSA).\n\nHYPOTHESIS:\n\nThe SPT+MAD combination is more cost-effective and effective, in means of reduction of the apnea-hypopnea index (AHI), quality of life and compliance, compared with CPAP.\n\nSTUDY DESIGN:\n\nA multicenter randomized clinical trial (RCT) will be performed with a follow-up of 12 months per patient. Patients will be randomized for CPAP or the combination SPT and MRA. All outcomes will be measured at baseline, month 3, 6 and 12.\n\nSTUDY POPULATION:\n\nPatients diagnosed with moderate POSA according to polysomnography (PSG) results.\n\nINTERVENTION / STANDARD INTERVENTION TO BE COMPARED TO:\n\nThe SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway pressure to open the airway; MRA is an intra-oral prosthesis, which holds the mandible in a protrusive position, all to prevent effectively apneic events.\n\nOUTCOME MEASURES:\n\nAHI, compliance, quality-adjusted life year (QALY), direct and indirect costs, cardiovascular parameters, incremental cost-effectiveness ratio (ICER)\n\nSAMPLE SIZE / DATA ANALYSIS:\n\n100 subjects in each treatment group, total of 200 patients.\n\nCOST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS:\n\nThe SPT is expected to improve the cost-effectiveness of overall treatment of POSA patients, and will save annually approximately 35-150 million euros.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* Ability to speak, read and write Dutch\n* Ability to follow up\n* Diagnosis with symptomatic moderate OSA (15 \\< AHI \\< 30)\n* Diagnosis of 10 to 90% supine position during the night\n* AHI supine is 2 \\> as high as AHI non-supine\n* Own a Windows PC and ability to install SPT connection software and upload research data\n* Expected to maintain current lifestyle (sports, medicine, diet etc.)\n\nExclusion Criteria:\n\n* Many dental problems; insufficient teeth for wearing MRA\n* Medication used/ related to sleeping disorders\n* Central Sleep Apnea Syndrome\n* Night or shifting work\n* Severe chronic heart failure\n* Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy)\n* Seizure disorder\n* Known medical history of mental retardation, memory disorders or psychiatric disorders\n* Shoulder, neck and back complaints\n* Reversible morphological upper airway abnormalities (e.g. enlarged tonsils)\n* Inability to provide informed consent\n* Simultaneous use of other treatment modalities to treat OSA\n* Previous treatment for OSA with MRA, CPAP or SPT\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02553902', 'briefTitle': 'Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Onze Lieve Vrouwe Gasthuis'}, 'officialTitle': 'Economic Evaluation of Treatment Modalities for Position Dependent Obstructive Sleep Apnea Patients', 'orgStudyIdInfo': {'id': 'NL52032.029.15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Combination therapy', 'description': 'Sleep Position Trainer + Mandibular Advancement device combination The SPT is a sensor that measures the sleeping position, and gives the user feedback about wrong positions with a soft vibration. A user is then able to react to the signal and turn into a non-supine position. To stimulate compliance, information is provided about nightly behaviour, implicating a learning pattern by viewing the data on a home computer.\n\nMRA or oral appliances (OA) works by advancing the mandible and its attached soft tissue structures forward they aim to increase upper airway size.', 'interventionNames': ['Device: Sleep position trainer', 'Device: Mandibular advancement device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CPAPContinuous positive airway pressure', 'description': 'Continuous positive airway pressure (CPAP) functions as a pneumatic splint to maintain upper airway patency. Possible side effect can be related to the interface, pressure and negative social factors.', 'interventionNames': ['Device: Continuous positive airway pressure']}], 'interventions': [{'name': 'Sleep position trainer', 'type': 'DEVICE', 'armGroupLabels': ['Combination therapy']}, {'name': 'Mandibular advancement device', 'type': 'DEVICE', 'otherNames': ['MRA, MAD'], 'armGroupLabels': ['Combination therapy']}, {'name': 'Continuous positive airway pressure', 'type': 'DEVICE', 'armGroupLabels': ['CPAPContinuous positive airway pressure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'O.M. Vanderveken, Professor', 'role': 'CONTACT'}], 'facility': 'Antwerp University Hospital (UZA)', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'N. de Vries, Professor', 'role': 'CONTACT', 'email': 'n.vries@olvg.nl'}, {'name': 'Patty Vonk, MD', 'role': 'CONTACT', 'email': 'researchkno@olvg.nl'}], 'facility': 'OLVG West', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Patty Vonk, MD', 'role': 'CONTACT', 'email': 'researchkno@olvg.nl'}, {'name': 'N de Vries, Professor', 'role': 'CONTACT', 'email': 'n.vries@slaz.nl'}], 'overallOfficials': [{'name': 'O.M. Vanderveken, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Onze Lieve Vrouwe Gasthuis', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Antwerp', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Drs.', 'investigatorFullName': 'L.B.L. Benoist', 'investigatorAffiliation': 'Onze Lieve Vrouwe Gasthuis'}}}}