Charleston, South Carolina 29403

  • Presbylarynx

Purpose:

Presbyphonia is an age-related voice disorder that affects more than 10 million people in the United States. Presbyphonia is characterized by vocal fold atrophy that impairs older individuals' ability to communicate, leading to social isolation and reduced quality of life. Outcomes from current treatment approaches are often suboptimal for patients with presbyphonia as they do not sufficiently challenge the respiratory system to induce meaningful change. It is highly likely that the addition of respiratory training would result in greatly improved outcomes, such as the ability to speak loud and long enough to have a normal conversation. The purpose of this study will be to examine the effect of adding inspiratory muscle strength training (IMST) or expiratory muscle strength training (EMST) to standard of care voice therapy on respiratory and voice outcomes in patients with an age-related voice disorder. Forty-eight participants diagnosed with presbyphonia will be blocked-randomized into three intervention groups, using a 3-parallel arm design: IMST and voice exercises, EMST and voice exercises, and voice exercises during all session. Study endpoints will be the change in voice and respiratory measures after four treatment sessions compared to baseline values. Response to treatment will be analyzed to determine if there are subgroups of high- or low-responders based on baseline voice and respiratory characteristics.


Criteria:

Inclusion Criteria: - must receive a diagnosis of presbyphonia by a trained laryngologist. The diagnosis will be given following a visual examination if the observations are consistent with the characteristics of a presbylarynx, as judged by the laryngologist. - must be 50 years old and older. Exclusion Criteria: - has received voice therapy in the past year - presents with a vocal fold pathology other than presbyphonia - has a known neurologic or a progressive neuromuscular disease - has a medical condition that could be aggravated by the experimental intervention, or any condition judged by the physician (Dr. Halstead) as being unsuitable for RMST. - has dysarthria or a language disorder - has a hearing loss that is not adequately managed - has a cognitive disorder that might affect treatment compliance - is unable to give informed consent


Study is Available At:


Original ID:

00064753


NCT ID:

NCT03557775


Secondary ID:


Study Acronym:


Brief Title:

Respiratory Muscle Strength Training in Presbyphonia


Official Title:

Respiratory Muscle Strength Training in Presbyphonia


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

50 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medical University of South Carolina


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

22


Enrollment Type:

Actual


Overall Contact Information

Official Name:Heather Bonilha, PhD
Principal Investigator
Medical University of South Carolina

Study Dates

Start Date:June 15, 2018
Completion Date:July 16, 2019
Completion Type:Actual
Primary Completion Date:June 25, 2019
Primary Completion Type:Actual
Verification Date:August 2020
Last Changed Date:August 19, 2020
First Received Date:May 22, 2018
First Results Date:June 24, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Post-Treatment Mean in Voice Handicap Index Score
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Voice Handicap Index-10 (ordinal scale that measures the degree of handicap a person experiences because of their voice disorder. Minimum score 0, maximal score 40. A lower score is better )
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in (Habitual) Sound Pressure Level
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Acoustic measure of loudness, in Decibels
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading)
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Acoustic measure of voice quality, in Decibels
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR)
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Acoustic measure of voice quality, expressed as a ratio of noise to harmonics in the signal.
Outcome Type:Secondary Outcome
Measure:Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ)
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Acoustic measure of voice quality, expressed as a percentage
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Overall Severity of Voice Quality
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:This is a auditory-perceptual measure rated on the standardized form: Consensus Auditory-Perceptual Evaluation of Voice (a 100-mm visual analogue scale where 0 represents a normal voice and 100 represents an extremely disrupted voice quality. A lower scor
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Baseline Bowing Index
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Measure of vocal fold atrophy, calculated as the length of the membranous vocal fold/distance from the edge x100. The index was calculated based on still images from the larynx obtained from videostroboscopy. A smaller bowing index is indicative of less a
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Ordinal scale measuring the impact of the communication disorder on various situations. A higher score is indicative of a more functional communication (the minimum score is 0 and the maximum score is 30).
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Glottal Function Index (GFI) Score
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Glottal Function Index (ordinal scale that measures the presence and degree of symptoms of glottal dysfunction experienced by a patient. Minimum score is 0, maximum score is 20. A lower score is better).
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Average Glottal Airflow
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Aerodynamic measure of voice expressed in Liters/second
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Average Subglottal Pressure
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Aerodynamic measure of voice expressed in cmH20
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Aerodynamic Resistance
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Aerodynamic measure (subglottal pressure divided by mean flow rate), expressed as cmH20/liters/second
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Maximum Expiratory Pressure (MEP)
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Maximum Inspiratory Pressure (MIP)
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Indirect measure of respiratory muscle strength, expressed in cmH20
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Forced Vital Capacity (FVC)
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Measure of pulmonary function, expressed as a percent predicted value
Outcome Type:Secondary Outcome
Measure:Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1)
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Measure of pulmonary function expressed as percent predicted value
Outcome Type:Secondary Outcome
Measure:Post-Treatment Mean for FEV1/FVC
Time Frame:up to 5 weeks after baseline
Safety Issues:False
Description:Pulmonary function measure expressed as percent predicted value (ratio between forced expiratory volume in one second and forced vital capacity)

Study Interventions

Intervention Type:Behavioral
Name:Voice Exercises
Description:Voice exercises will consist of the Vocal Function Exercises (VFE) protocol, developed by Stemple (2005). It contains 4 steps: (a) sustain the vowel /i/ on the musical note F for as long as possible. Repeat as judged by the SLP. (b) Glide from the lowest note to the highest note. Repeat as judged by the SLP. (c) Glide from the highest note to the lowest note. Repeat as judged by the SLP. (d) Sustain the notes C-D-E-F-G for as long as possible. Each note will be repeated until the participant fin
Arm Name:Expiratory Muscle Strength Training
Intervention Type:Device
Name:Expiratory Muscle Strength Training (EMST)
Description:EMST will be conducted using an expiratory pressure threshold trainer (EMST150®), which consists of a mouthpiece with a spring-loaded valve. The valve blocks the airflow until the threshold pressure is achieved by breathing out forcefully into the device. This allows airflow as long as the sufficient pressure is maintained.
Arm Name:Expiratory Muscle Strength Training
Other Name:Expiratory muscle training (EMT)
Intervention Type:Device
Name:Inspiratory Muscle Strength Training (IMST)
Description:IMST will be conducted using an inspiratory pressure threshold trainer (Philips Respironics® Threshold IMT or POWERbreathe® Medic Plus), which consists of a mouthpiece with a spring-loaded valve. The valve blocks the airflow until the threshold pressure is achieved by breathing in forcefully into the device. This allows airflow as long as the sufficient pressure is maintained.
Arm Name:Inspiratory Muscle Strength Training
Other Name:Inspiratory muscle training (IMT)

Study Arms

Study Arm Type:Experimental
Arm Name:Inspiratory Muscle Strength Training
Description:The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST). The IMST intervention will consist of 5 sets of 5 breaths in the inspiratory threshold device every day during four weeks, with a loading dose set at 75% of the participants' maximal inspiratory pressure (MIP). MIP will be measured once a week during the weekly supervised session to adjust the inspiratory trainer.
Study Arm Type:Experimental
Arm Name:Expiratory Muscle Strength Training
Description:The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST). The EMST intervention will consist of 5 sets of 5 breaths in the expiratory threshold device every day during four weeks, with a loading dose set at 75% of the participants' maximal expiratory pressure (MEP). MEP will be measured once a week during the weekly supervised session to adjust the inspiratory trainer.
Study Arm Type:Active Comparator
Arm Name:Voice Exercises
Description:The participants in the voice exercises group will receive standard of care voice therapy with a speech language pathologist, once a week during four weeks, plus daily practices.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Medical University of South Carolina

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 02, 2021

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