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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
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.
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.
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 finds the right placement (forward-focused voice), as judged by the SLP. Humming will be used to facilitate placement.
Medical University of South Carolina
Charleston, South Carolina, United States
Post-Treatment Mean in Voice Handicap Index Score
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 )
Time frame: up to 5 weeks after baseline
Post-treatment Mean in (Habitual) Sound Pressure Level
Acoustic measure of loudness, in Decibels
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading)
Acoustic measure of voice quality, in Decibels
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR)
Acoustic measure of voice quality, expressed as a ratio of noise to harmonics in the signal.
Time frame: up to 5 weeks after baseline
Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ)
Acoustic measure of voice quality, expressed as a percentage
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Overall Severity of Voice Quality
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).
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Baseline Bowing Index
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.
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score
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).
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Glottal Function Index (GFI) Score
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).
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Average Glottal Airflow
Aerodynamic measure of voice expressed in Liters/second
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Average Subglottal Pressure
Aerodynamic measure of voice expressed in cmH20
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Aerodynamic Resistance
Aerodynamic measure (subglottal pressure divided by mean flow rate), expressed as cmH20/liters/second
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Maximum Expiratory Pressure (MEP)
Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Maximum Inspiratory Pressure (MIP)
Indirect measure of respiratory muscle strength, expressed in cmH20
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Forced Vital Capacity (FVC)
Measure of pulmonary function, expressed as a percent predicted value
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1)
Measure of pulmonary function expressed as percent predicted value
Time frame: up to 5 weeks after baseline
Post-Treatment Mean for FEV1/FVC
Pulmonary function measure expressed as percent predicted value (ratio between forced expiratory volume in one second and forced vital capacity)
Time frame: up to 5 weeks after baseline
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