PresbylarynxNCT03557775
Respiratory Muscle Strength Training in Presbyphonia
A study testing Inspiratory Muscle Strength Training (IMST), Expiratory Muscle Strength Training (EMST) and Voice Exercises in people with Presbylarynx, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Presbylarynx
- What is being tested?
- Inspiratory Muscle Strength Training (IMST), Expiratory Muscle Strength Training (EMST) and Voice Exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 16 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29403
About this study
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.
- Conditions
- Presbylarynx
- Being tested
- Inspiratory Muscle Strength Training (IMST), Expiratory Muscle Strength Training (EMST), Voice Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Strength Training (IMST)Device
Also called Inspiratory muscle training (IMT), Respiratory muscle training (RMT), Respiratory muscle strength training (RMST), Philips Respironics® Threshold IMT
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.
Expiratory Muscle Strength Training (EMST)Device
Also called Expiratory muscle training (EMT), Respiratory muscle training (RMT), Respiratory muscle strength training (RMST), EMST150®
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 ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Strength Training | Experimental | 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. Receives: Device: Inspiratory Muscle Strength Training (IMST); Behavioral: Voice Exercises |
| Expiratory Muscle Strength Training | Experimental | 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. Receives: Device: Expiratory Muscle Strength Training (EMST); Behavioral: Voice Exercises |
| Voice Exercises | Active comparator | 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. Receives: Behavioral: Voice Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: up to 5 weeks after baseline
Secondary outcomes (16)
Post-treatment Mean in (Habitual) Sound Pressure Level
Acoustic measure of loudness, in Decibels
Measured: 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
Measured: 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.
Measured: up to 5 weeks after baseline
Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ)
Acoustic measure of voice quality, expressed as a percentage
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: up to 5 weeks after baseline
Post-treatment Mean in Average Glottal Airflow
Aerodynamic measure of voice expressed in Liters/second
Measured: up to 5 weeks after baseline
Post-treatment Mean in Average Subglottal Pressure
Aerodynamic measure of voice expressed in cmH20
Measured: 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
Measured: up to 5 weeks after baseline
Post-treatment Mean in Maximum Expiratory Pressure (MEP)
Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20
Measured: up to 5 weeks after baseline
Post-treatment Mean in Maximum Inspiratory Pressure (MIP)
Indirect measure of respiratory muscle strength, expressed in cmH20
Measured: up to 5 weeks after baseline
Post-treatment Mean in Forced Vital Capacity (FVC)
Measure of pulmonary function, expressed as a percent predicted value
Measured: 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
Measured: 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)
Measured: up to 5 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start15 Jun 2018
- Primary completion25 Jun 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PresbylarynxStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Bonilha, PhD, Principal investigator, Medical University of South CarolinaMaude Desjardins, M.Sc., Study director, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557775
- Sponsor's protocol ID
- 00064753
- Status last verified
- Aug 2020
- First submitted
- 22 May 2018
- Last updated
- 7 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Strength Training in Presbyphonia
- ClinicalTrials.gov ID
- NCT03557775
- Acronym / sponsor ID
- 00064753
- Conditions
- Presbylarynx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 7 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Strength Training | Experimental | Device: Inspiratory Muscle Strength Training (IMST), Behavioral: Voice ExercisesThe 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. |
| Expiratory Muscle Strength Training | Experimental | Device: Expiratory Muscle Strength Training (EMST), Behavioral: Voice ExercisesThe 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. |
| Voice Exercises | Active comparator | Behavioral: Voice ExercisesThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle Strength Training (IMST)Also: Inspiratory muscle training (IMT), Respiratory muscle training (RMT), Respiratory muscle strength training (RMST), Philips Respironics® Threshold IMTIMST 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. | Device | Inspiratory Muscle Strength Training |
| Expiratory Muscle Strength Training (EMST)Also: Expiratory muscle training (EMT), Respiratory muscle training (RMT), Respiratory muscle strength training (RMST), EMST150®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. | Device | Expiratory Muscle Strength Training |
| Voice ExercisesVoice 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. | Behavioural | Expiratory Muscle Strength Training, Inspiratory Muscle Strength Training, Voice Exercises |
Primary outcome
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 )
16 secondary outcomes
Post-treatment Mean in (Habitual) Sound Pressure Level
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading)
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR)
Time frame: up to 5 weeks after baseline
Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ)
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Overall Severity of Voice Quality
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Baseline Bowing Index
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Glottal Function Index (GFI) Score
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Average Glottal Airflow
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Average Subglottal Pressure
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Aerodynamic Resistance
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Maximum Expiratory Pressure (MEP)
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Maximum Inspiratory Pressure (MIP)
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Forced Vital Capacity (FVC)
Time frame: up to 5 weeks after baseline
Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: up to 5 weeks after baseline
Post-Treatment Mean for FEV1/FVC
Time frame: up to 5 weeks after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Presbylarynx
Active, not recruiting
Improving Voice Production for Adults With Age-related Dysphonia
Presbylarynx, Age-Related Dysphonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Bonilha, PhD principal investigator
Medical University of South Carolina
Maude Desjardins, M.Sc. study director
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Strength Training (IMST), Expiratory Muscle Strength Training (EMST) and Voice Exercises in people with Presbylarynx, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Treatment Mean in Voice Handicap Index Score (time frame: up to 5 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.