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

Primary Purpose

Voice Disorder, Vocal Cord Atrophy, Presbyphonia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMST
PhoRTE
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Voice Disorder

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Emory University Hospital Midtown
  • University of Pittsburgh Voice Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PhoRTE

PhoRTE + EMST

Arm Description

This group will undergo standard PhoRTE therapy.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

AVI Score at Baseline and Follow up (5 Weeks)
The Aging Voice Index (AVI) is a validated instrument that measures quality of life in older adults with voice disorders. A higher score indicates worse quality of life. Scores range from 0 to 92.
Maximum Expiratory Pressure (MEP)
Maximum Expiratory Pressure (MEP) was measured using a handheld manometer (Micro Direct Respiratory Pressure Meter, MicroRPM, Med-Electronics, Beltsville, MD, United States) at baseline and after 5 weeks of therapy. Participants were instructed to blow with maximum force into the MicroRPM device over 10 trials, and the participant's best three trials were used to calculate their average MEP.
Phonatory Airflow in Speech at Baseline and 5 Weeks
Aerodynamic measures were collected and analyzed via the Phonatory Aerodynamic System 6600 (PAS; PENTAX Medical, Montvale, NJ, United States) using the first four sentences of the Rainbow Passage. Aerodynamic measures included mean airflow during voicing and number of breaths taken. The PAS captured phonatory aerodynamic functioning using a pneumotach coupled to a facemask, with external microphone. During speech, expired air flows through the pneumotach, which consists of a stainless-steel mesh screen with pressure transducers on either side. The system calculates the pressure difference across the screen to determine airflow rate. The microphone is positioned at the end of the pneumotach and internally calibrated per system specifications to represent a mouth-to-microphone distance of 15 cm. The participant sat with the facemask held snugly over their nose and mouth while they read the first fou
Number of Breaths at Baseline and Follow up (5 Weeks)
Aerodynamic measurement: mean number of breaths in reading of a standard passage (The Rainbow Passage).
Mean Cepstral Spectral Index of Dysphonia (CSID) Measurements While Reading Functional Phrases at Baseline and 5 Weeks
Cepstral Spectral Index of Dysphonia (CSID) is a multifactorial estimate of dysphonia severity that correlates with an auditory perceptual rating of overall voice severity using a 0-100 visual analog scale. Components of the algorithm include the cepstral peak prominence and its standard deviation, the low to high spectral ratio and its standard deviation. Typically, CSID limits are 0-100, but very severe voices may exceed 100, and very periodic, normal voices may be less than 0.
Cepstral Spectral Index of Dysphonia (CSID) Measurements at Baseline and 5 Weeks
Cepstral Spectral Index of Dysphonia (CSID) is a multifactorial estimate of dysphonia severity that correlates with an auditory perceptual rating of overall voice severity using a 0-100 visual analog scale. Components of the algorithm include the cepstral peak prominence and its standard deviation, the low to high spectral ratio and its standard deviation. Typically, CSID limits are 0-100, but very severe voices may exceed 100, and very periodic, normal voices may be less than 0.
Duration of Standard Reading Passage at Baseline and Follow up (5 Weeks)
Aerodynamic measurement; mean duration to complete the reading of a standard passage (The Rainbow Passage).
Cepstral Peak Prominence at Baseline and 5 Weeks Follow up
Acoustic measurement: Cepstral Peak Prominence and its standard deviation while reading functional phrases.
Cepstral Peak Prominence (CPP) Fundamental Frequency (F0) at Baseline and Follow up (5 Weeks)
Acoustic measurement: CPP F0 while reading functional phrases.
Mean Fundamental Frequency in Sentence at Baseline and at 5 Weeks
Aerodynamic measurement: mean F0 in reading of a standard passage (The Rainbow Passage).
Vocal Intensity at Baseline and Follow up
Acoustic measurement: mean vocal intensity in dB SPL while reading functional phrases.
Mean Change In Overall Voice Severity at 5 Weeks
Overall voice severity determined by Consensus Auditory Perceptual Evaluation - Voice (CAPE-V) score provided by blinded raters. The visual analog scale for overall voice severity used. Minimum score = 0, Maximum score = 100. Higher values indicate worse voice.

Full Information

First Posted
September 20, 2018
Last Updated
August 4, 2021
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03696576
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to the pandemic, recruitment ended earlier than expected and changes were required to alter data collection methods (and were approved by the IRB). Additional changes were also made to the protocol to move the study to an online platform.
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
May 4, 2020 (Actual)
Study Completion Date
May 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voice Disorder, Vocal Cord Atrophy, Presbyphonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Speech Language Pathologists (SLPs) will not know which group the participants have been randomized to.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PhoRTE
Arm Type
Active Comparator
Arm Description
This group will undergo standard PhoRTE therapy.
Arm Title
PhoRTE + EMST
Arm Type
Experimental
Arm Description
This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
Intervention Type
Device
Intervention Name(s)
EMST
Intervention Description
Training of the respiratory system muscles using the EMST device.
Intervention Type
Behavioral
Intervention Name(s)
PhoRTE
Intervention Description
Completing of PhoRTE voice therapy.
Primary Outcome Measure Information:
Title
Voice Handicap Index-10 (VHI-10) Score
Description
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.
Time Frame
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 Outcome Measure Information:
Title
AVI Score at Baseline and Follow up (5 Weeks)
Description
The Aging Voice Index (AVI) is a validated instrument that measures quality of life in older adults with voice disorders. A higher score indicates worse quality of life. Scores range from 0 to 92.
Time Frame
At initial therapy visit (Baseline) and final follow up-visit (Follow up - week 5)
Title
Maximum Expiratory Pressure (MEP)
Description
Maximum Expiratory Pressure (MEP) was measured using a handheld manometer (Micro Direct Respiratory Pressure Meter, MicroRPM, Med-Electronics, Beltsville, MD, United States) at baseline and after 5 weeks of therapy. Participants were instructed to blow with maximum force into the MicroRPM device over 10 trials, and the participant's best three trials were used to calculate their average MEP.
Time Frame
At initial therapy visit (Baseline) and final follow up-visit (week 5)
Title
Phonatory Airflow in Speech at Baseline and 5 Weeks
Description
Aerodynamic measures were collected and analyzed via the Phonatory Aerodynamic System 6600 (PAS; PENTAX Medical, Montvale, NJ, United States) using the first four sentences of the Rainbow Passage. Aerodynamic measures included mean airflow during voicing and number of breaths taken. The PAS captured phonatory aerodynamic functioning using a pneumotach coupled to a facemask, with external microphone. During speech, expired air flows through the pneumotach, which consists of a stainless-steel mesh screen with pressure transducers on either side. The system calculates the pressure difference across the screen to determine airflow rate. The microphone is positioned at the end of the pneumotach and internally calibrated per system specifications to represent a mouth-to-microphone distance of 15 cm. The participant sat with the facemask held snugly over their nose and mouth while they read the first fou
Time Frame
At initial therapy visit (Baseline) and final follow up-visit (week 5)
Title
Number of Breaths at Baseline and Follow up (5 Weeks)
Description
Aerodynamic measurement: mean number of breaths in reading of a standard passage (The Rainbow Passage).
Time Frame
At initial therapy visit (Baseline) and final follow up-visit (week 5)
Title
Mean Cepstral Spectral Index of Dysphonia (CSID) Measurements While Reading Functional Phrases at Baseline and 5 Weeks
Description
Cepstral Spectral Index of Dysphonia (CSID) is a multifactorial estimate of dysphonia severity that correlates with an auditory perceptual rating of overall voice severity using a 0-100 visual analog scale. Components of the algorithm include the cepstral peak prominence and its standard deviation, the low to high spectral ratio and its standard deviation. Typically, CSID limits are 0-100, but very severe voices may exceed 100, and very periodic, normal voices may be less than 0.
Time Frame
Baseline (At initial therapy visit) and final follow up-visit (week 5)
Title
Cepstral Spectral Index of Dysphonia (CSID) Measurements at Baseline and 5 Weeks
Description
Cepstral Spectral Index of Dysphonia (CSID) is a multifactorial estimate of dysphonia severity that correlates with an auditory perceptual rating of overall voice severity using a 0-100 visual analog scale. Components of the algorithm include the cepstral peak prominence and its standard deviation, the low to high spectral ratio and its standard deviation. Typically, CSID limits are 0-100, but very severe voices may exceed 100, and very periodic, normal voices may be less than 0.
Time Frame
Baseline (At initial therapy visit) and final follow up-visit (week 5)
Title
Duration of Standard Reading Passage at Baseline and Follow up (5 Weeks)
Description
Aerodynamic measurement; mean duration to complete the reading of a standard passage (The Rainbow Passage).
Time Frame
At initial therapy visit (Baseline) and final follow up-visit (week 5)
Title
Cepstral Peak Prominence at Baseline and 5 Weeks Follow up
Description
Acoustic measurement: Cepstral Peak Prominence and its standard deviation while reading functional phrases.
Time Frame
At initial therapy visit (Baseline) and final follow up-visit (after week 5)
Title
Cepstral Peak Prominence (CPP) Fundamental Frequency (F0) at Baseline and Follow up (5 Weeks)
Description
Acoustic measurement: CPP F0 while reading functional phrases.
Time Frame
At initial therapy visit (Baseline) and final follow up-visit (week 5)
Title
Mean Fundamental Frequency in Sentence at Baseline and at 5 Weeks
Description
Aerodynamic measurement: mean F0 in reading of a standard passage (The Rainbow Passage).
Time Frame
At initial therapy visit (Baseline) and final follow up-visit (week 5)
Title
Vocal Intensity at Baseline and Follow up
Description
Acoustic measurement: mean vocal intensity in dB SPL while reading functional phrases.
Time Frame
At initial therapy visit (baseline) and final follow up-visit (week 5)
Title
Mean Change In Overall Voice Severity at 5 Weeks
Description
Overall voice severity determined by Consensus Auditory Perceptual Evaluation - Voice (CAPE-V) score provided by blinded raters. The visual analog scale for overall voice severity used. Minimum score = 0, Maximum score = 100. Higher values indicate worse voice.
Time Frame
At initial therapy visit and final follow up-visit, after week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Gillespie
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
University of Pittsburgh Voice Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
only de-identified data will be shared
IPD Sharing Time Frame
during and through data analysis
IPD Sharing Access Criteria
additional researchers may receive de-identified information only if a data use agreement has been executed.
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Expiratory Muscle Strength Training and Phonation Resistance Training Exercises For Elderly Patients With Vocal Fold Atrophy

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