Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-28 @ 1:03 PM
Study NCT ID:
NCT01289392
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2011-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Continuous Positive Airway Pressure (CPAP), Oral Appliance and Physical Exercise in the Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D045422', 'term': 'Continuous Positive Airway Pressure'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schutzferraz@gmail.com', 'phone': '55-21-99868033', 'title': 'Dr Teresa Cristina Barros Schutz', 'organization': 'Associação Fundo de Incentivo à Pesquisa'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Continuous Positive Airway Pressure (CPAP)', 'description': 'CPAP is the gold standard treatment\n\nContinuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oral Appliance', 'description': 'Alternative treatment for obstructive sleep apnea patients\n\nOral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Physical Exercise', 'description': 'Aerobic and resistance physical exercises\n\nPhysical Exercise : aerobic and resistance Physical exercise, three times a week, for four months', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Sleep Parameters', 'timeFrame': '6 months after the basal evaluation', 'description': 'Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Inflammatory Markers', 'timeFrame': '6 months after the basal evaluation', 'description': 'Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Sleep Apnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Positive Airway Pressure (CPAP)', 'description': 'CPAP is the gold standard treatment\n\nContinuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise'}, {'id': 'OG001', 'title': 'Oral Appliance', 'description': 'Alternative treatment for obstructive sleep apnea patients\n\nOral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise'}, {'id': 'OG002', 'title': 'Physical Exercise', 'description': 'Aerobic and resistance physical exercises\n\nPhysical Exercise : aerobic and resistance Physical exercise, three times a week, for four months'}], 'classes': [{'categories': [{'measurements': [{'value': '25.06', 'spread': '10.54', 'groupId': 'OG000'}, {'value': '30.76', 'spread': '19.00', 'groupId': 'OG001'}, {'value': '22.81', 'spread': '12.77', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Number of events per hour of sleep', 'unitOfMeasure': 'number of events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Continuous Positive Airway Pressure (CPAP)', 'description': 'CPAP is the gold standard treatment\n\nContinuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise'}, {'id': 'FG001', 'title': 'Oral Appliance', 'description': 'Alternative treatment for obstructive sleep apnea patients\n\nOral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise'}, {'id': 'FG002', 'title': 'Physical Exercise', 'description': 'Aerobic and resistance physical exercises\n\nPhysical Exercise : aerobic and resistance Physical exercise, three times a week, for four months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'sleep disorder clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Continuous Positive Airway Pressure (CPAP)', 'description': 'CPAP is the gold standard treatment\n\nContinuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise'}, {'id': 'BG001', 'title': 'Oral Appliance', 'description': 'Alternative treatment for obstructive sleep apnea patients\n\nOral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise'}, {'id': 'BG002', 'title': 'Physical Exercise', 'description': 'Aerobic and resistance physical exercises\n\nPhysical Exercise : aerobic and resistance Physical exercise, three times a week, for four months'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.62', 'spread': '8.15', 'groupId': 'BG000'}, {'value': '42.33', 'spread': '6.20', 'groupId': 'BG001'}, {'value': '42.28', 'spread': '8.28', 'groupId': 'BG002'}, {'value': '41.10', 'spread': '7.27', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'lastUpdateSubmitDate': '2013-04-25', 'studyFirstSubmitDate': '2011-01-31', 'resultsFirstSubmitDate': '2013-01-28', 'studyFirstSubmitQcDate': '2011-02-02', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-04', 'studyFirstPostDateStruct': {'date': '2011-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Sleep Parameters', 'timeFrame': '6 months after the basal evaluation', 'description': 'Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation'}, {'measure': 'Sleep Apnea', 'timeFrame': '6 months', 'description': 'Number of events per hour of sleep'}], 'secondaryOutcomes': [{'measure': 'Inflammatory Markers', 'timeFrame': '6 months after the basal evaluation', 'description': 'Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'CPAP', 'Oral appliance', 'Aerobic exercise', 'Resistance training'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '24037015', 'type': 'DERIVED', 'citation': "Schutz TC, Cunha TC, Moura-Guimaraes T, Luz GP, Ackel-D'Elia C, Alves Eda S, Pantiga G Jr, Mello MT, Tufik S, Bittencourt L. Comparison of the effects of continuous positive airway pressure, oral appliance and exercise training in obstructive sleep apnea syndrome. Clinics (Sao Paulo). 2013;68(8):1168-74. doi: 10.6061/clinics/2013(08)17."}]}, 'descriptionModule': {'briefSummary': 'Introduction: It is unclear whether exercise training with or without Continuous Positive Airway Pressure (CPAP) and Oral Appliance (OA) is more effective in reducing symptoms of Obstructive Sleep Apnea (OSA) than treatment solely with CPAP or OA.\n\nObjective: In patients with moderate OSA, the investigators will evaluate the effect on the subjective and objective measures of sleep, quality of life and mood of different forms of treatment: exercise training of 4 months; exercise training of 4 months associated with CPAP and OA; treatment with CPAP and treatment with OA.\n\nMaterial and Methods: Sixty male patients (25-65 years, sedentary lifestyle, Body Mass Index (BMI) \\< 35kg/m2, Apnea-Hypopnea Index (AHI) between 15-30/h, Epworth sleepiness scale \\> 9) will be divided into three groups: CPAP+exercise group (CE; n=20), OA+exercise group (AE; n=20), and Exercise training group (E; n=20). The patients in groups CE and AE will complete two months of treatment with CPAP or OA to examine the separate effects of these devices. As the patients of the E group did not use the CPAP but will undergo four months of exercise training. After this initial step, patients in CE and AE groups will undergo four months of exercise training associated with CPAP or OA. The investigators will evaluate the subjective sleep parameters (sleep disorders questionnaire, the Epworth Sleepiness Scale, sleep diaries) and objective (polysomnography), Short Form Health Survey (SF-36), Questionnaire Profile of Mood States (POMS) and anthropometric measurements (neck circumference and body composition), the incremental exercise test (ergospirometry) and the one Repetition Maximum test (1RM).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects aged between 25 and 65 years old\n* Sedentary according to the criteria of Godin and Shephard (1985) and / or ACSM (2000)\n* Epworth Sleepiness Scale over score of nine\n* Normal range of laboratory tests \\[blood count, cholesterol, High-density lipoprotein (HDL), triglycerides, fasting glucose, creatinine, Thyroid-stimulating hormone (TSH)\\]\n* Lung function test (spirometry), chest X-ray (for smokers and former smokers) electrocardiogram (rest and stress) and ENT examination without significant changes\n\nExclusion Criteria:\n\n* Presence of clinical diseases (chronic obstructive pulmonary disease, asthma, interstitial lung diseases, neuromuscular diseases, heart failure, thyroid disease, rheumatologic and psychiatric) and other sleep disorders\n* Presence of anatomical obstructive upper airway, tonsil grade III and IV septal deviation and grade III (severe) that may affect the outcome of CPAP\n* Loss of posterior dental support to undermine the retention of oral appliance\n* Active periodontal disease, compared Dental crown / dental root less than or equal to 1 (c / r ≤ 1), need for primary dental care (cavities, root canal treatment or retreatment, dentures, ie outlying), open bite\n* Protrusive displacement less than five millimeters\n* Limited mouth opening (would prevent the forming of the dental arches)\n* Alcoholism\n* Uuse of sleep-inducing medications\n* Habits or occupations that lead to sleep deprivation or alteration of the sleep-wake cycle\n* Inability to perform physical exercise, regular history sports activities\n* Intolerance to Continuous Positive Airway Pressure (CPAP)\n* Obesity grade II (moderate) and III (severe)'}, 'identificationModule': {'nctId': 'NCT01289392', 'briefTitle': 'Continuous Positive Airway Pressure (CPAP), Oral Appliance and Physical Exercise in the Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Associação Fundo de Incentivo à Pesquisa'}, 'officialTitle': 'Effects of the Treatment With Continuous Positive Airway Pressure (CPAP) and Oral Appliance, Associated or Not Associated With Physical Exercise, in the Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'CEP 0352/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Positive Airway Pressure (CPAP)', 'description': 'CPAP is the gold standard treatment', 'interventionNames': ['Device: Continuous Positive Airway Pressure (CPAP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Appliance', 'description': 'Alternative treatment for obstructive sleep apnea patients', 'interventionNames': ['Device: Oral Appliance (OA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical Exercise', 'description': 'Aerobic and resistance physical exercises', 'interventionNames': ['Behavioral: Physical Exercise']}], 'interventions': [{'name': 'Continuous Positive Airway Pressure (CPAP)', 'type': 'DEVICE', 'description': 'Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise', 'armGroupLabels': ['Continuous Positive Airway Pressure (CPAP)']}, {'name': 'Oral Appliance (OA)', 'type': 'DEVICE', 'description': 'Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise', 'armGroupLabels': ['Oral Appliance']}, {'name': 'Physical Exercise', 'type': 'BEHAVIORAL', 'description': 'aerobic and resistance Physical exercise, three times a week, for four months', 'armGroupLabels': ['Physical Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04024-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Sono/Associação Fundo de Incentivo a Psicofarmacologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Associação Fundo de Incentivo à Pesquisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Prof. Dr. Lia Azeredo-Bittencourt', 'investigatorAffiliation': 'Associação Fundo de Incentivo à Pesquisa'}}}}