Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 4:55 AM
Study NCT ID:
NCT01315535
Status:
UNKNOWN
Last Update Posted:
2011-06-23
First Post:
2011-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fast Titration of Oral Appliance at Obstructive Sleep Apnea Syndrome (OSAS) Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-21', 'studyFirstSubmitDate': '2011-03-14', 'studyFirstSubmitQcDate': '2011-03-14', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mandibular Advancement', 'Oral Appliance', 'TMD'], 'conditions': ['Obstructive Sleep Apnea Syndrome']}, 'descriptionModule': {'briefSummary': 'The literature does not discuss if the fast oral appliance titration (30 days period) in Obstructive Sleep Apnea Syndrome (OSAS) treatment, may improve subjects quality of life in such brief period. Temporomandibular dysfunction-related (TMD) is one of the most important side effects observed in OSAS treatment with oral appliance. Since the effectiveness of mandibular exercises in the control of TMD pain has already been verified, it may play a fundamental role in the support of the fast oral appliance titration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects diagnosed with mild to moderate osas, according to the aasm criteria (2005) from the respiratory disorders clinic (UNIFESP) referred to oral appliance treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≤ 35kg/m2\n* MILD TO MODERATE OSAS DIAGNOSIS ACCORDING TO THE AASM CRITERIA (2005)\n* Negative TMD diagnosis (according to RDC/TMD)\n\nExclusion Criteria:\n\n* DENTAL CONDITIONS THAT CONTRAINDICATED THE ORAL APLLIANCE USAGE\n* SLEEP DISORDERS OTHER THAN OSAS'}, 'identificationModule': {'nctId': 'NCT01315535', 'briefTitle': 'Fast Titration of Oral Appliance at Obstructive Sleep Apnea Syndrome (OSAS) Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Associacao Fundo de Incentivo a Psicofarmcologia'}, 'officialTitle': 'Evaluation of the Efficacy and Side Effects of Fast Mandibular Advancement With Oral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome', 'orgStudyIdInfo': {'id': 'CEP0301/10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fast Titration'}, {'label': 'Regular Titration'}, {'label': 'Fast Tritation Including Mandibular Exercises'}, {'label': 'Regular Tritation Including Mandibular Exercises'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04039-032', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'LIA BITTENCOURT, PhD', 'role': 'CONTACT', 'email': 'lia@pscicobio.epm.br', 'phone': '055-11-8234-1166'}, {'name': 'PAULO CUNALI, PhD', 'role': 'CONTACT', 'email': 'pacunali@onda.com.br', 'phone': '055-41-96868668'}, {'name': 'LIA BITTENCOURT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'PAULO CUNALI, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto Do Sono / Universidade Federal de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Associacao Fundo de Incentivo a Psicofarmcologia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'BITTENCOURT, LIA R. A. / PhD', 'oldOrganization': 'UNIFESP'}}}}