EMST And PhoRTE Training For Elderly Patients With Vocal Fold Atrophy
Sponsor:
Jacqueline Gartner-Schmidt
Collaborators:
Information provided by (Responsible Party):
Jacqueline Gartner-Schmidt，University of Pittsburgh
| Tracking Information | |||
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| First Submitted Date ICMJE | September 20, 2018 | ||
| First Posted Date ICMJE | October 4, 2018 | ||
| Last Update Posted Date | October 4, 2018 | ||
| Actual Study Start Date ICMJE | October 2018 | ||
| Estimated Primary Completion Date | July 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Mean Change From Baseline VHI-10 Score at 5 Weeks[ Time Frame: At each study visit through study completion; Time 0 (therapy visit1), after week 1 (therapy visit 2), after week 2 (therapy visit 3), after week 3 (therapy visit 4), after week 5 (follow up visit) ] The Voice Handicap Index-10 (VHI-10) is a validated assessment instrument that quantifies patient perceptions of his or her own voice handicap. A lower score on the VHI-10 indicates perception of a lesser voice handicap than a high score. Scores range from 0 to 40. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | EMST And PhoRTE Training For Elderly Patients With Vocal Fold Atrophy |
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| Official Title ICMJE | EMST And PhoRTE Training For Elderly Patients With Vocal Fold Atrophy |
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| Brief Summary | The larynx and vocal folds undergo many age-related changes in their physiology and structure that can lead to undesirable effects on the voice, with changes in the respiratory system compounding these deficits. These changes, also called presbyphonia, can have serious detrimental effects on the lives of elderly individuals. There are few studies that have evaluated the use of voice therapy treatment options for these patients. The primary aim of this study is to test whether the addition of expiratory muscle strength training (EMST) to a current, validated voice therapy protocol aimed at treating presbyphonia, (phonation resistance training, PhoRTE) can improve outcomes of therapy. |
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| Detailed Description | The purpose of this study is to test whether the addition of EMST to PhoRTE Voice Therapy is at least as effective as PhoRTE alone for improving acoustic, aerodynamic, and patient-reported outcomes in patients affected by age-related vocal fold atrophy. Voice therapy is often the first-line treatment for patients experiencing presbyphonia. Despite being the most common treatment for presbyphonia, scant literature exists on the efficacy of voice therapy for these patients. The current proposal aims to add to this growing body of literature. In general, studies of existing voice therapy programs for presbyphonia have demonstrated success in achieving improvement in aerodynamic (increased subglottal pressure), acoustic (increased shimmer, jitter, and decreased noise-to-harmonics ratio), and patient-centered outcomes (reduction in Voice Handicap Index scores, decreased phonatory effort). Ziegler et al. conducted a study comparing a standard voice therapy, Vocal Function Exercises (VFE) and Phonation Resistance Training Exercises (PhoRTE) and found that both therapies improved outcomes of voice-related quality of life, but only PhoRTE gave a statistically significant reduction in perceived phonatory effort. A specific therapy designed to address age-related changes to respiratory system is expiratory muscle strength training (EMST). EMST devices are loaded with a resistive spring which opens when a desired level of expiratory pressure is reached and maintained. Maintenance of consistent subglottal pressure is the foundation for phonation. EMST device training improves active expiratory muscle forces required for high-pressure activities such as long utterances or loud speech in vocally healthy individuals. When used in conjunction with traditional voice therapy, EMST use has also shown to increase maximum phonation time, maximum expiratory pressure, dynamic range, subglottal pressure, and perception of voice handicap in professional voice users over traditional voice therapy alone. The theoretical underpinnings for treatment of vocal fold atrophy with EMST are clear, as it addresses many of the common goals of treatment in patients with presbyphonia, but it has not yet been tested as a possible adjunctive treatment for patients undergoing voice therapy. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description:Speech Language Pathologists (SLPs) will not know which group the participants have been randomized to. Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
42 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | July 2019 | ||
| Estimated Primary Completion Date | July 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Age 65 or older - Diagnosis of presbyphonia (vocal fold atrophy) made by a fellowship-trained laryngologist and a voice specialized speech language pathologist - Willingness to be randomized to one of two treatments Exclusion Criteria: - Any concomitant laryngeal diagnoses or diseases known to affect voice function, including: amyloidosis, arytenoid dislocation, laryngeal cancer, cricoarytenoid fixation, vocal fold cyst(s), vocal nodules, vocal fold polyp(s), dysplasia, vocal fold fibrous mass(es), glottal web, vocal fold immobility, laryngeal stenosis, laryngocele, leukoplakia, Parkinson's disease, Reinke's edema, respiratory recurrent pneumonia, sarcoidosis, spasmodic dysphonia - Any chronic lower airway disease such as chronic obstructive pulmonary disease (COPD), asthma, chronic bronchitis, emphysema, cystic fibrosis - History of acute stroke - Untreated hypertension - Untreated gastroesophageal reflux disease (GERD) | ||
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| Ages | 65 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: Yes |
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| IPD Sharing Statement |
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| Responsible Party | Jacqueline Gartner-Schmidt，University of Pittsburgh | ||
| Study Sponsor ICMJE | Jacqueline Gartner-Schmidt | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | University of Pittsburgh | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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