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Completed

NCT Number: NCT03557775

Respiratory Muscle Strength Training in Presbyphonia

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.

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Key information

Conditions

Presbylarynx

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Strength Training (IMST)

Device

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.

Other names: Inspiratory muscle training (IMT), Respiratory muscle training (RMT), Respiratory muscle strength training (RMST), Philips Respironics® Threshold IMT, POWERbreathe® Medic Plus

Expiratory Muscle Strength Training (EMST)

Device

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.

Other names: Expiratory muscle training (EMT), Respiratory muscle training (RMT), Respiratory muscle strength training (RMST), EMST150®

Voice Exercises

Behavioral

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.

Primary outcomes

  1. Post-Treatment Mean in Voice Handicap Index Score

    Time frame: 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 )

Secondary outcomes

  1. Post-treatment Mean in (Habitual) Sound Pressure Level

    Time frame: up to 5 weeks after baseline

    Acoustic measure of loudness, in Decibels

  2. Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading)

    Time frame: up to 5 weeks after baseline

    Acoustic measure of voice quality, in Decibels

  3. Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR)

    Time frame: up to 5 weeks after baseline

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

  4. Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ)

    Time frame: up to 5 weeks after baseline

    Acoustic measure of voice quality, expressed as a percentage

  5. Post-treatment Mean in Overall Severity of Voice Quality

    Time frame: 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).

  6. Post-treatment Mean in Baseline Bowing Index

    Time frame: 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.

  7. Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score

    Time frame: 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).

  8. Post-treatment Mean in Glottal Function Index (GFI) Score

    Time frame: 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).

  9. Post-treatment Mean in Average Glottal Airflow

    Time frame: up to 5 weeks after baseline

    Aerodynamic measure of voice expressed in Liters/second

  10. Post-treatment Mean in Average Subglottal Pressure

    Time frame: up to 5 weeks after baseline

    Aerodynamic measure of voice expressed in cmH20

  11. Post-treatment Mean in Aerodynamic Resistance

    Time frame: up to 5 weeks after baseline

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

  12. Post-treatment Mean in Maximum Expiratory Pressure (MEP)

    Time frame: up to 5 weeks after baseline

    Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20

  13. Post-treatment Mean in Maximum Inspiratory Pressure (MIP)

    Time frame: up to 5 weeks after baseline

    Indirect measure of respiratory muscle strength, expressed in cmH20

  14. Post-treatment Mean in Forced Vital Capacity (FVC)

    Time frame: up to 5 weeks after baseline

    Measure of pulmonary function, expressed as a percent predicted value

  15. Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: up to 5 weeks after baseline

    Measure of pulmonary function expressed as percent predicted value

  16. Post-Treatment Mean for FEV1/FVC

    Time frame: up to 5 weeks after baseline

    Pulmonary function measure expressed as percent predicted value (ratio between forced expiratory volume in one second and forced vital capacity)

Other outcomes

  1. Voice-Vibratory Assessment With Laryngeal Imaging

    Time frame: up to 5 weeks after baseline

    exploratory measure

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2018
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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