Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT01289405
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2011-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phonoaudiologic Therapy Adjunct to Treatment on 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': 'D003147', 'term': 'Communication 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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-02-05', 'studyFirstSubmitDate': '2011-02-01', 'studyFirstSubmitQcDate': '2011-02-02', 'lastUpdatePostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'objective sleep pattern', 'timeFrame': '90 days', 'description': 'sleep stages, arousals, apnea-hypopnea index, oxyhemoglobin saturation evaluated by polysomnography'}], 'secondaryOutcomes': [{'measure': 'somnolence', 'timeFrame': '90 days', 'description': 'score of Epworth Sleepiness Scale'}, {'measure': 'Quality of Life', 'timeFrame': '90 days', 'description': 'score of WHOQOL-BREF and FOSQ questionnaires'}, {'measure': 'Cognition', 'timeFrame': '90 days', 'description': 'Evaluations of Psychomotor Vigilance Test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obstructive sleep apnea', 'oropharyngeal exercises', 'speech therapy'], 'conditions': ['Obstructive Sleep Apnea Syndrome']}, 'referencesModule': {'references': [{'pmid': '27913971', 'type': 'DERIVED', 'citation': 'Diaferia G, Santos-Silva R, Truksinas E, Haddad FLM, Santos R, Bommarito S, Gregorio LC, Tufik S, Bittencourt L. Myofunctional therapy improves adherence to continuous positive airway pressure treatment. Sleep Breath. 2017 May;21(2):387-395. doi: 10.1007/s11325-016-1429-6. Epub 2016 Dec 2.'}]}, 'descriptionModule': {'briefSummary': 'Objective: to evaluate the effects of a speech therapy exercises program in the treatment of Obstructive Sleep Apna Syndrome (OSAS) patients based on the clinical and polysomnography (PSG) parameters.\n\nMethods: 80 patients with OSAS will be evaluated: men, 25-65 years old, body mass index \\< 35 kg/m2 and scores of Epworth Sleepiness Scale \\> 9. Patients will be divided into four groups: I: 20 patients with OSAS underwent speech therapy; II: 20 patients with OSAS underwent placebo therapy of Speech Therapy; III: 20 patients starting treatment with CPAP underwent speech therapy; IV: 20 patients starting treatment with CPAP without speech therapy or placebo. The speech therapy include isometric and isotonic exercises to improve posture, mobility and muscle tone of the soft palate, pharyngeal constrictor muscles, tip and base of tongue, cheeks and lips. Placebo therapy includes relaxation exercises and stretching neck, without therapeutic purpose. Both therapies are applied for three months, three times a day, lasting 20 minutes each session. During the treatment, the subjects will be monitored in weekly meetings, for orientation and description of the exercises and return of the fulfilled exercises diary. The subjects will also be followed at the CPAP clinic in returns after one week, a month and at the end of the study. Conduct assessments before and after treatment and after twenty one days washout, including: assessing the upper airway, anthropometric investigation of the facial skeleton and speech of Orofacial, questionnaires (Epworth Sleepiness Scale, FOSQ, General Segment and use of CPAP, WHOQOL-BREF, snoring), Psychomotor Vigilance Test and PSG.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a recent diagnosis of OSAS\n* Body mass index (BMI) \\< 35 kg/m2\n\nExclusion Criteria:\n\n* Facial malformations\n* Regular use of hypnotic medications\n* Hypothyroidism\n* Previous stroke\n* Neuromuscular disease\n* Heart failure\n* Coronary disease\n* Severe obstructive nasal disease'}, 'identificationModule': {'nctId': 'NCT01289405', 'briefTitle': 'Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Associação Fundo de Incentivo à Pesquisa'}, 'officialTitle': 'Phonoaudiologic Therapy as an Adjunct to the Continuous Positive Airway Pressure Treatment on Patients With Obstructive Sleep Apnea Syndrome', 'orgStudyIdInfo': {'id': 'CEP 2002/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo exercices', 'description': 'relaxation exercises and stretching neck, without therapeutic purpose.', 'interventionNames': ['Device: Continuous Positive Airway Pressure (CPAP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'phonoaudiologic therapy', 'description': 'isometric and isotonic exercises to improve posture, mobility and muscle tone of the soft palate, pharyngeal constrictor muscles, tip and base of tongue, cheeks and lips.', 'interventionNames': ['Device: Continuous Positive Airway Pressure (CPAP)']}], 'interventions': [{'name': 'Continuous Positive Airway Pressure (CPAP)', 'type': 'DEVICE', 'description': 'mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea', 'armGroupLabels': ['phonoaudiologic therapy', 'placebo exercices']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04024-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Associação Fundo de Incentivo a Psicofarmacologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Lia Rita A Bittencourt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal de São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Associação Fundo de Incentivo à Pesquisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Prof. Dr. Lia Azeredo-Bittencourt', 'investigatorAffiliation': 'Associação Fundo de Incentivo à Pesquisa'}}}}