N/A
N=20
Respiratory Muscle Strength Training in Presbyphonia
Presbylarynx
Bottom Line
View on ClinicalTrials.gov: NCT03557775 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Post-Treatment Mean in Voice Handicap Index Score — 15.00; 15.75; 18.50 score on a scale — p=0.041
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inspiratory Muscle Strength Training (IMST) (Device); Expiratory Muscle Strength Training (EMST) (Device); Voice Exercises (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-Treatment Mean in Voice Handicap Index Score |
15.00; 15.75; 18.50 | 0.041 sig |
| SECONDARY Post-treatment Mean in (Habitual) Sound Pressure Level |
73.18; 70.73; 74.75 | 0.887 |
| SECONDARY Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading) |
18.03; 16.74; 17.86 | 0.733 |
| SECONDARY Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR) |
0.13; 0.16; 0.12 | 0.702 |
| SECONDARY Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ) |
2.91; 4.25; 3.05 | 0.198 |
| SECONDARY Post-treatment Mean in Overall Severity of Voice Quality |
21.00; 31.25; 35.00 | 0.388 |
| SECONDARY Post-treatment Mean in Baseline Bowing Index |
9.03; 5.76; 8.97 | 0.296 |
| SECONDARY Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score |
24.00; 19.50; 14.75 | 0.040 sig |
| SECONDARY Post-treatment Mean in Glottal Function Index (GFI) Score |
9.75; 8.75; 8.75 | 0.887 |
| SECONDARY Post-treatment Mean in Average Glottal Airflow |
0.10; 0.27; 0.18 | 0.663 |
| SECONDARY Post-treatment Mean in Average Subglottal Pressure |
6.37; 6.47; 5.99 | 0.026 sig |
| SECONDARY Post-treatment Mean in Aerodynamic Resistance |
63.43; 21.25; 37.11 | 0.721 |
| SECONDARY Post-treatment Mean in Maximum Expiratory Pressure (MEP) |
121.00; 176.25; 131.00 | 0.408 |
| SECONDARY Post-treatment Mean in Maximum Inspiratory Pressure (MIP) |
98.75; 84.50; 81.50 | 0.638 |
| SECONDARY Post-treatment Mean in Forced Vital Capacity (FVC) |
80.75; 80.75; 94.00 | 0.715 |
| SECONDARY Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1) |
75.75; 73.00; 94.00 | 0.708 |
| SECONDARY Post-Treatment Mean for FEV1/FVC |
94.00; 87.75; 99.00 | 0.988 |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03557775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.