Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT01636856
Status:
UNKNOWN
Last Update Posted:
2014-05-28
First Post:
2012-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Oropharyngeal Exercises on Patients With Primary Snore, Mild and Moderate Obstructive
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D012913', 'term': 'Snoring'}], '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'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055556', 'term': 'Nasal Lavage'}], 'ancestors': [{'id': 'D007507', 'term': 'Therapeutic Irrigation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2012-07-05', 'studyFirstSubmitQcDate': '2012-07-05', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper airway collapsability', 'timeFrame': '3 months'}, {'measure': 'Images from magnetic resonance', 'timeFrame': '3 months'}, {'measure': 'Negative expiratory pressure', 'timeFrame': '3 months'}, {'measure': 'Snore', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Sleep related questionnaires', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['oropharyngeal exercises, obstructive sleep apnea, speech therapy, magnetic resonance, PCRIT, negative expiratory pressure, snore'], 'conditions': ['Primary Snore, Obstructive Sleep Apnea (Mild and Moderate).']}, 'referencesModule': {'references': [{'pmid': '25950418', 'type': 'DERIVED', 'citation': 'Ieto V, Kayamori F, Montes MI, Hirata RP, Gregorio MG, Alencar AM, Drager LF, Genta PR, Lorenzi-Filho G. Effects of Oropharyngeal Exercises on Snoring: A Randomized Trial. Chest. 2015 Sep;148(3):683-691. doi: 10.1378/chest.14-2953.'}]}, 'descriptionModule': {'briefSummary': 'Randomized study of patients with primary snore, mild and moderate obstructive sleep apnea. Protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator, breathing exercise and nasal lavage. The objectives are study the effects of therapy on oropharyngeal in a series of clinical and physiologic and anatomic variables, changes on snore and quality of sleep using Pharyngeal Critical Pressure, Magnetic Resonance, Negative expiratory pressure and snore analyses. Hypothesis that the therapy group (oropharyngeal exercises) will have more modifications compared to the control group.', 'detailedDescription': 'This is randomized study with multiple primary endpoints. In December 2012 the study also started collecting tongue strength and endurance (IOPI). Because not all patients are able to perform all evaluations, the publications will be divided and presented according to the completion of the required number of patients for each primary endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nsubjects with primary snore, mild and moderate obstructive sleep apnea\n\nExclusion Criteria:\n\nBMI \\> or = 40, craniofacial malformations, smokers, pregnant women, edentulous, total dental prostheses, use of hypnotic medications, stroke, neuromuscular dystrophy, coronary artery disease, chronic heart failure, chronic obstructive pulmonary disease, severe nasal obstructive disease, pharyngeal surgery,already made some kind of treatment for obstructive sleep apnea.'}, 'identificationModule': {'nctId': 'NCT01636856', 'acronym': 'EOE', 'briefTitle': 'Effects of Oropharyngeal Exercises on Patients With Primary Snore, Mild and Moderate Obstructive', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Oropharyngeal Exercises on Snoring Intensity, Symptoms, Upper Airway Anatomy and Collapsability of Upper Airway Awake and Asleep in Patients With Primary Snoring and Mild to Moderate Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '3604/11/022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Oropharyngeal exercises and oropharyngeal functions', 'interventionNames': ['Behavioral: Oropharyngeal exercises']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': 'Nasal dilator, respiratory exercise, nasal lavage', 'interventionNames': ['Behavioral: Respiratory exercises, nasal dilator, nasal lavage']}], 'interventions': [{'name': 'Oropharyngeal exercises', 'type': 'BEHAVIORAL', 'description': 'Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.', 'armGroupLabels': ['1']}, {'name': 'Respiratory exercises, nasal dilator, nasal lavage', 'type': 'BEHAVIORAL', 'description': 'Respiratory exercises, nasal dilator, nasal lavage', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-904', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Geraldo Lorenzi-Filho, MD, PhD', 'role': 'CONTACT', 'email': 'geraldo.lorenzi@gmail.com', 'phone': '55 (0xx) 11- 2661-5486'}, {'name': 'Pedro Rodrigues Genta, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fabiane Kayamori', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vanessa Ieto', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Incor- Heart Institute, Sleep Laboratory', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Geraldo Lorenzi-Filho, MD, PhD', 'role': 'CONTACT', 'email': 'geraldo.lorenzi@incor.usp.br', 'phone': '55-XX-11-26615486'}], 'overallOfficials': [{'name': 'Vanessa Ieto', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute - InCor'}, {'name': 'Fabiane Kayamori', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute - InCor'}, {'name': 'Geraldo Lorenzi-Filho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute - InCor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor of Pulmonary Division', 'investigatorFullName': 'Geraldo Lorenzi-Filho', 'investigatorAffiliation': 'University of Sao Paulo'}}}}