Clinical trial NCT03696576: Expiratory Muscle Strength Training and Phonation Resistance Training Exercises For Elderly Patients With Vocal Fold Atrophy
Official title: EMST And PhoRTE Training For Elderly Patients With Vocal Fold Atrophy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Voice Disorder
Vocal Cord Atrophy
Presbyphonia
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Voice Handicap Index-10 (VHI-10) Score
timeFrame: At each study visit through study completion; Time 0 (therapy visit 1-Baseline), follow-up week 1 (therapy visit 2), follow-up week 2 (therapy visit 3),follow-up week 3 (therapy visit 4), follow-up week 5 (follow up visit)
Secondary outcomes:
measure: AVI Score at Baseline and Follow up (5 Weeks)
timeFrame: At initial therapy visit (Baseline) and final follow up-visit (Follow up - week 5)
measure: Maximum Expiratory Pressure (MEP)
timeFrame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
measure: Phonatory Airflow in Speech at Baseline and 5 Weeks
timeFrame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
measure: Number of Breaths at Baseline and Follow up (5 Weeks)
timeFrame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
measure: Mean Cepstral Spectral Index of Dysphonia (CSID) Measurements While Reading Functional Phrases at Baseline and 5 Weeks
timeFrame: Baseline (At initial therapy visit) and final follow up-visit (week 5)
measure: Cepstral Spectral Index of Dysphonia (CSID) Measurements at Baseline and 5 Weeks
timeFrame: Baseline (At initial therapy visit) and final follow up-visit (week 5)
measure: Duration of Standard Reading Passage at Baseline and Follow up (5 Weeks)
timeFrame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
measure: Cepstral Peak Prominence at Baseline and 5 Weeks Follow up
timeFrame: At initial therapy visit (Baseline) and final follow up-visit (after week 5)
measure: Cepstral Peak Prominence (CPP) Fundamental Frequency (F0) at Baseline and Follow up (5 Weeks)
timeFrame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
measure: Mean Fundamental Frequency in Sentence at Baseline and at 5 Weeks
timeFrame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
measure: Vocal Intensity at Baseline and Follow up
timeFrame: At initial therapy visit (baseline) and final follow up-visit (week 5)
measure: Mean Change In Overall Voice Severity at 5 Weeks
timeFrame: At initial therapy visit and final follow up-visit, after week 5
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Pittsburgh
country: United States
facility: University of Pittsburgh Voice Center
state: Pennsylvania
Study officials:
affiliation: Emory University
name: Amanda Gillespie
role: PRINCIPAL_INVESTIGATOR
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