Expiratory Muscle Strength Training and Phonation Resistance Training Exercises For Elderly Patients With Vocal Fold Atrophy

NCT03696576 | Terminated Results FDA Device

• 2 other identifiers: IRB00109224PRO18040682
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Voice Disorder; Vocal Cord Atrophy; Presbyphonia

Outcome Measures

Primary Outcomes (1)

• Voice Handicap Index-10 (VHI-10) Score

  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.

  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 (12)

• AVI Score at Baseline and Follow up (5 Weeks)

  At initial therapy visit (Baseline) and final follow up-visit (Follow up - week 5)

• Maximum Expiratory Pressure (MEP)

  At initial therapy visit (Baseline) and final follow up-visit (week 5)

• Phonatory Airflow in Speech at Baseline and 5 Weeks

  At initial therapy visit (Baseline) and final follow up-visit (week 5)

• Number of Breaths at Baseline and Follow up (5 Weeks)

  At initial therapy visit (Baseline) and final follow up-visit (week 5)

• Mean Cepstral Spectral Index of Dysphonia (CSID) Measurements While Reading Functional Phrases at Baseline and 5 Weeks

  Baseline (At initial therapy visit) and final follow up-visit (week 5)

Study Arms (2)

PhoRTE

ACTIVE COMPARATOR

This group will undergo standard PhoRTE therapy.

Behavioral: PhoRTE

PhoRTE + EMST

EXPERIMENTAL

This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.

Device: EMST; Behavioral: PhoRTE

Interventions

EMST DEVICE

Training of the respiratory system muscles using the EMST device.

PhoRTE + EMST

PhoRTE BEHAVIORAL

Completing of PhoRTE voice therapy.

PhoRTE; PhoRTE + EMST

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

University of Pittsburgh Voice Center

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (35)

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  BACKGROUND

MeSH Terms

Conditions

Voice Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sandeep Shelly
• Organization: Emory University

SSHELLY@emory.edu

404-686-4206

Study Officials

• Amanda Gillespie

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Speech Language Pathologists (SLPs) will not know which group the participants have been randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant professor

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 4, 2018
• Study Start: September 20, 2018
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: August 30, 2021
• Results First Posted: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: during and through data analysis
• Access Criteria: additional researchers may receive de-identified information only if a data use agreement has been executed.

Locations

US (2)