Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT01022320
Status:
UNKNOWN
Last Update Posted:
2009-12-01
First Post:
2009-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea (OSA) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-11-30', 'studyFirstSubmitDate': '2009-11-30', 'studyFirstSubmitQcDate': '2009-11-30', 'lastUpdatePostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OSA', 'Blood pressure', 'Lateral Pharyngoplasty'], 'conditions': ['Obstructive Sleep Apnea', 'High Blood Pressure']}, 'descriptionModule': {'briefSummary': '* Describe blood pressure changes on patients with OSA treated with lateral pharyngoplasty\n* Compare the mean of systolic and diastolic blood pressure in 24 hours, average systolic and diastolic pressure during daytime and night and changes in the nocturnal decrease.', 'detailedDescription': 'The variables are:\n\nAmbulatory blood pressure data Snoring scale BMI neck circumference abdominal circumference medications and life style changes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Patient\n* BMI \\< 35\n* no Benzodiazepinec User\n\nExclusion Criteria:\n\n* BMI \\> 35\n* Use of benzodiazepinecs\n* Clinical contra-indications to surgery (ASA III or ASA IV)'}, 'identificationModule': {'nctId': 'NCT01022320', 'briefTitle': 'Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea (OSA) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Servidor Publico Estadual'}, 'officialTitle': 'Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea Patients', 'orgStudyIdInfo': {'id': '0024.0.338.000-09'}, 'secondaryIdInfos': [{'id': 'HSPE-001/09', 'type': 'REGISTRY', 'domain': 'Otorhinolaryngology department of HSPE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgical outcome', 'description': '20 consecutive cases of patients who underwent the lateral pharyngoplasty', 'interventionNames': ['Procedure: Lateral Pharyngoplasty']}], 'interventions': [{'name': 'Lateral Pharyngoplasty', 'type': 'PROCEDURE', 'description': 'surgery lateral pharyngoplasty: consists on the section and rotation of the superior constrictor pharyngeal muscle associated with the ressection of the palatopharyngeus preserving the palatoglossus and mucosa of posterior and anterior tonsilar pillar , bilaterally.', 'armGroupLabels': ['Surgical outcome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '040000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Carolina Soares, MD', 'role': 'CONTACT', 'email': 'naliroca@hotmail.com'}, {'name': 'Michel Cahali, MD', 'role': 'CONTACT', 'email': 'mcahali@igmail.com'}, {'name': 'Carolina Soares, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital do Servidor Estadual de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Carolina Soares, MD', 'role': 'CONTACT', 'email': 'naliroca@hotmail.com', 'phone': '+551184856036'}, {'name': 'Michel Cahali, MD', 'role': 'CONTACT', 'phone': '+5088800'}], 'overallOfficials': [{'name': 'Carolina Soares, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HSPE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Servidor Publico Estadual', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Carolina Ferraz de Paula Soares', 'oldOrganization': 'HSPE'}}}}