Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-16 @ 9:12 AM
Study NCT ID:
NCT02724657
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2016-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buteyko Method for Asthmatic Children With Mouth Breathing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D009058', 'term': 'Mouth Breathing'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-20', 'studyFirstSubmitDate': '2016-03-07', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Sleep disturbance (questionnaire)', 'timeFrame': 'Baseline, three weeks later and six months after treatment', 'description': 'Sleep disturbance will be assessed by the sleep disturbance scale for children (SDSC).'}], 'secondaryOutcomes': [{'measure': 'Change in spirometry (FVC, FEV1, FEV1/FVC, FEF25-75%, PEF)', 'timeFrame': 'Baseline, three weeks later and six months after treatment'}, {'measure': 'Change in ventilometry (minute volume and vital capacity)', 'timeFrame': 'Baseline, three weeks later and six months after treatment', 'description': 'Minute volume and vital capacity (liters)'}, {'measure': 'Number of hospitalizations', 'timeFrame': 'Through study completion, an average of three weeks and six months after treatment'}, {'measure': 'Number of days off-school', 'timeFrame': 'During the three weeks of treatment'}]}, 'conditionsModule': {'keywords': ['Child', 'Breathing exercises'], 'conditions': ['Asthma', 'Mouth Breathing']}, 'descriptionModule': {'briefSummary': 'To assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of asthmatic children with mouth breathing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children from 7 up to 12 years old with asthma diagnose\n* Regular inhaled corticosteroids with no change in dose in the preceding 4 weeks.\n* Children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, and tuberculosis), retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations.\n\nExclusion Criteria:\n\n* Children that are not able to perform some of the necessary procedures, give up participating in the research and present acute symptoms of respiratory tract during the assessments.'}, 'identificationModule': {'nctId': 'NCT02724657', 'briefTitle': 'Buteyko Method for Asthmatic Children With Mouth Breathing', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio Grande do Norte'}, 'officialTitle': 'THE EFFECTS OF THE BUTEYKO METHOD IN MOUTH BREATHING ASTHMATIC CHILDREN: A CONTROLLED RANDOMIZED STUDY', 'orgStudyIdInfo': {'id': '1.443.588'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buteyko Method', 'description': 'Children will perform 6 sessions (twice a week) of treatment with the Buteyko Method.', 'interventionNames': ['Other: Buteyko Method']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Asthma education.'}], 'interventions': [{'name': 'Buteyko Method', 'type': 'OTHER', 'description': 'Intervention will be held twice a week during 3 weeks.', 'armGroupLabels': ['Buteyko Method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59078970', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'country': 'Brazil', 'facility': 'Universidade Federal do Rio Grande do Norte (UFRN)', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio Grande do Norte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Karla Morganna Pereira Pinto de Mendonça', 'investigatorAffiliation': 'Universidade Federal do Rio Grande do Norte'}}}}