Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-05 @ 1:55 AM
Study NCT ID:
NCT03692494
Status:
WITHDRAWN
Last Update Posted:
2025-02-07
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055154', 'term': 'Dysphonia'}, {'id': 'D014826', 'term': 'Vocal Cord Paralysis'}], 'ancestors': [{'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020421', 'term': 'Vagus Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI did decided reorganize the methodology for this study and will resubmit in the future.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2018-09-30', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum expiratory pressure', 'timeFrame': '16 weeks', 'description': 'Maximum expiratory pressure, in cm of H2O, will be measured to evaluate how much pressure a participant can blow into a respiratory pressure meter.'}, {'measure': 'Amplitude', 'timeFrame': '16 weeks', 'description': 'Amplitude of voice, in decibels, will be measured using Voice Range Profile on Kay Pentax CSL and will be compared to gender matched normative values for normal and loud volumes.'}], 'secondaryOutcomes': [{'measure': 'Fundamental frequency', 'timeFrame': '16 weeks', 'description': 'Fundamental frequency, measured in herz, will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.'}, {'measure': 'Dynamic pitch range', 'timeFrame': '16 weeks', 'description': 'Dynamic pitch range will be measured using Voice Range Profile on Kay Pentax Computerized Speech Lab.'}, {'measure': 'Cepstral Peak Prominence (CPP)', 'timeFrame': '16 weeks', 'description': 'Cepstral Peak Prominence will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.'}, {'measure': 'Cepstral spectral index of dysphonia (CSID)', 'timeFrame': '16 weeks', 'description': 'Cepstral spectral index of dysphonia, will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.'}, {'measure': 'Voice Handicap Index', 'timeFrame': '16 weeks', 'description': 'This is quality of life assessment tool quantifying perception of the impact of their vocal disorder on various aspects of lifestyle. It is 30-questions in length and is divided into 3 subscales including emotional, physical, and functional, divided into 10 questions each. Each question scored from 0-4. Total score range from 0-120. Higher score indicates increased handicap.'}, {'measure': 'Maximum phonation time', 'timeFrame': '16 weeks', 'description': 'The patient will be asked to inhale deeply and sustain the vowel /a/ at a comfortable loudness level for a many seconds as possible.'}, {'measure': 'Peak expiratory flow rate', 'timeFrame': '16 weeks', 'description': 'Peak expiratory flow rate, measured in units of liters per minute, will be measured for purposes of measuring cough function.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysphonia', 'Unilateral Vocal Cord Paralysis']}, 'descriptionModule': {'briefSummary': 'Evaluate if adding expiratory muscle strength training to traditional voice therapy for individuals with dysphonia due to glottal insufficiency improves maximal expiratory pressure, acoustic and aerodynamic measures (i.e. amplitude, maximum phonation time, peak expiratory flow), and voice related quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals with glottic insufficiency.\n* Adequate cognition evidenced by score of 24 or higher on the Mini-Mental State Examination (MMSE) survey to determine if the subject has the mental capacity to participate in therapy\n* Completed voice combination evaluation with speech pathologists and otolaryngologist.\n* Individuals 18 years of age or older\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Non English or Spanish speakers\n* Pregnant women\n* Prisoners\n* Individuals with significant uncontrolled chronic and progressive respiratory diseases including COPD, interstitial lung disease, and cystic fibrosis.\n* Individuals with uncontrolled blood pressure.\n* Individuals with significant GI disease and/or gastroesophageal surgery with the exception of well-controlled GERD.\n* Individuals with a history of abdominal hernia.\n* Individuals with difficulty complying due to neuropsychological dysfunction (e.g., severe depression, psychosis).\n* Individuals with other neurological disorders and/or neuromuscular disease other than Parkinson's Disease"}, 'identificationModule': {'nctId': 'NCT03692494', 'briefTitle': 'The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy', 'orgStudyIdInfo': {'id': '20171103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unilateral vocal fold paralysis standard of care voice therapy', 'description': 'The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques.', 'interventionNames': ['Other: Standard of care voice therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Unilateral paralysis standard of care voice therapy plus EMST', 'description': 'The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. EMST consists of blowing into respiratory device at a measure threshold pressure. As strength improves threshold resistance will be increased.', 'interventionNames': ['Other: Standard of care voice therapy', 'Other: Expiratory muscle strength training (EMST)']}, {'type': 'EXPERIMENTAL', 'label': "Parkinson's disease standard of care voice therapy plus EMST", 'description': 'The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. EMST consists of blowing into respiratory device at a measure threshold pressure. As strength improves threshold resistance will be increased.', 'interventionNames': ['Other: Standard of care voice therapy', 'Other: Expiratory muscle strength training (EMST)']}], 'interventions': [{'name': 'Standard of care voice therapy', 'type': 'OTHER', 'description': 'Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder', 'armGroupLabels': ["Parkinson's disease standard of care voice therapy plus EMST", 'Unilateral paralysis standard of care voice therapy plus EMST', 'Unilateral vocal fold paralysis standard of care voice therapy']}, {'name': 'Expiratory muscle strength training (EMST)', 'type': 'OTHER', 'description': 'EMST150 used at 75% of their maximum expiratory pressure. Participants will be directed to perform 5 sets of 5 breaths, 5 days per week, for 5 weeks, at the pressure threshold established in therapy. Maximum expiratory pressure will then be determined at the beginning of each therapy session and recalibration of the device will be performed if indicated.', 'armGroupLabels': ["Parkinson's disease standard of care voice therapy plus EMST", 'Unilateral paralysis standard of care voice therapy plus EMST']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Adam T Lloyd, SLP-D, MM, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Speech Pathologist', 'investigatorFullName': 'Adam Lloyd', 'investigatorAffiliation': 'University of Miami'}}}}