Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT01335594
Status:
COMPLETED
Last Update Posted:
2012-04-10
First Post:
2011-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Swallowing in Patients With Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], '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': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-07', 'studyFirstSubmitDate': '2011-04-11', 'studyFirstSubmitQcDate': '2011-04-13', 'lastUpdatePostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical evaluation of swallowing in obstructive sleep apnea', 'timeFrame': 'within the first 3 months after diagnostic'}], 'secondaryOutcomes': [{'measure': 'Manometric evaluation of swallowing in obstructive sleep apnea', 'timeFrame': 'within the first 3 months after diagnostic'}, {'measure': 'Endoscopic evaluation of swallowing in obstructive sleep apnea', 'timeFrame': 'within the first 3 months after diagnostic'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep apnea, obstructive', 'Deglutition Disorders', 'Manometry', 'Endoscopy'], 'conditions': ['Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of obstructive sleep apnea syndrome\n\nExclusion Criteria:\n\n* other causes of dysphagia\n* pharyngeal surgery\n* prior treatment for obstructive sleep apnea'}, 'identificationModule': {'nctId': 'NCT01335594', 'briefTitle': 'Evaluation of Swallowing in Patients With Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Servidor Publico Estadual'}, 'officialTitle': 'Clinical, Endoscopical and Manometric Evaluation of Swallowing in Obstructive Sleep Apnea Syndrome', 'orgStudyIdInfo': {'id': 'SAOS2011'}}, 'armsInterventionsModule': {'interventions': [{'name': 'clinical, endoscopical and manometric evaluation', 'type': 'PROCEDURE', 'description': 'clinical evaluation: questionnaire endoscopical analysis manometry'}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto de Assistência Médica ao Servidor Público Estadual', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Luciana A M da Paz Oliveira', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luciana Almeida Moreira da Paz Oliveira', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'physician', 'investigatorFullName': 'Luciana Almeida Moreira da Paz Oliveira', 'investigatorAffiliation': 'Hospital do Servidor Publico Estadual'}}}}