NCT03557775

Respiratory Muscle Strength Training in Presbyphonia

Completed NA Results posted Last updated 7 September 2020

What this trial tests

NA trial testing Inspiratory Muscle Strength Training (IMST) in Presbylarynx in 22 participants. Completed in 16 July 2019.

Timeline

15 June 2018

Primary endpoint
25 June 2019

16 July 2019

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	22
Start date	15 June 2018
Primary completion	25 June 2019
Estimated completion	16 July 2019
Sites	1 location across United States

Drugs / interventions tested

• Inspiratory Muscle Strength Training (IMST)
• Expiratory Muscle Strength Training (EMST)
• Voice Exercises

Conditions studied

• Presbylarynx — all drugs for Presbylarynx →

Sponsor

Medical University of South Carolina

Who can join

50 and older, any sex, with Presbylarynx. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Post-Treatment Mean in Voice Handicap Index Score Primary · up to 5 weeks after baseline

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 )

Group	Value	95% CI
Inspiratory Muscle Strength Training	15.00	± 4.97
Expiratory Muscle Strength Training	15.75	± 8.77
Voice Exercises	18.50	± 10.66

Post-treatment Mean in (Habitual) Sound Pressure Level Secondary · up to 5 weeks after baseline

Acoustic measure of loudness, in Decibels

Group	Value	95% CI
Inspiratory Muscle Strength Training	73.18	± 5.29
Expiratory Muscle Strength Training	70.73	± 1.65
Voice Exercises	74.75	± 2.60

Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading) Secondary · up to 5 weeks after baseline

Acoustic measure of voice quality, in Decibels

Group	Value	95% CI
Inspiratory Muscle Strength Training	18.03	± 1.83
Expiratory Muscle Strength Training	16.74	± 0.52
Voice Exercises	17.86	± 1.06

Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR) Secondary · up to 5 weeks after baseline

Acoustic measure of voice quality, expressed as a ratio of noise to harmonics in the signal.

Group	Value	95% CI
Inspiratory Muscle Strength Training	0.13	± 0.02
Expiratory Muscle Strength Training	0.16	± 0.06
Voice Exercises	0.12	± 0.01

Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ) Secondary · up to 5 weeks after baseline

Acoustic measure of voice quality, expressed as a percentage

Group	Value	95% CI
Inspiratory Muscle Strength Training	2.91	± 1.04
Expiratory Muscle Strength Training	4.25	± 2.56
Voice Exercises	3.05	± 0.60

Post-treatment Mean in Overall Severity of Voice Quality Secondary · up to 5 weeks after baseline

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 score is better).

Group	Value	95% CI
Inspiratory Muscle Strength Training	21.00	± 10.61
Expiratory Muscle Strength Training	31.25	± 28.65
Voice Exercises	35.00	± 17.78

Post-treatment Mean in Baseline Bowing Index Secondary · up to 5 weeks after baseline

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 atrophy, and is therefore a better outcome. A greater bowing index is indicative of more atrophy and represent a worse outcome.

Group	Value	95% CI
Inspiratory Muscle Strength Training	9.03	± 3.35
Expiratory Muscle Strength Training	5.76	± 0.96
Voice Exercises	8.97	± 1.05

Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score Secondary · up to 5 weeks after baseline

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).

Group	Value	95% CI
Inspiratory Muscle Strength Training	24.00	± 1.00
Expiratory Muscle Strength Training	19.50	± 7.14
Voice Exercises	14.75	± 7.27

Post-treatment Mean in Glottal Function Index (GFI) Score Secondary · up to 5 weeks after baseline

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).

Group	Value	95% CI
Inspiratory Muscle Strength Training	9.75	± 4.03
Expiratory Muscle Strength Training	8.75	± 4.27
Voice Exercises	8.75	± 5.50

Post-treatment Mean in Average Glottal Airflow Secondary · up to 5 weeks after baseline

Aerodynamic measure of voice expressed in Liters/second

Group	Value	95% CI
Inspiratory Muscle Strength Training	0.10	± 0.06
Expiratory Muscle Strength Training	0.27	± 0.06
Voice Exercises	0.18	± 0.08

Post-treatment Mean in Average Subglottal Pressure Secondary · up to 5 weeks after baseline

Aerodynamic measure of voice expressed in cmH20

Group	Value	95% CI
Inspiratory Muscle Strength Training	6.37	± 2.33
Expiratory Muscle Strength Training	6.47	± 1.96
Voice Exercises	5.99	± 0.32

Post-treatment Mean in Aerodynamic Resistance Secondary · up to 5 weeks after baseline

Aerodynamic measure (subglottal pressure divided by mean flow rate), expressed as cmH20/liters/second

Group	Value	95% CI
Inspiratory Muscle Strength Training	63.43	± 17.07
Expiratory Muscle Strength Training	21.25	± 7.71
Voice Exercises	37.11	± 15.11

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Inspiratory Muscle Strength Training

Serious: 0/5 (0%)

Deaths: 0/5

Expiratory Muscle Strength Training

Serious: 0/7 (0%)

Deaths: 0/7

Voice Exercises

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (2 terms — click to expand)

Reaction	System	Inspiratory Muscle Strengt…	Expiratory Muscle Strength…	Voice Exercises
Skin irritation	Skin and subcutaneous tissue disorders	—	—	—
Transient aching	Respiratory, thoracic and mediastinal disorders	—	—	—

Data from ClinicalTrials.gov NCT03557775 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.