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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ) | up to 5 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Post-treatment Mean in (Habitual) Sound Pressure Level | Acoustic measure of loudness, in Decibels | up to 5 weeks after baseline |
| Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading) |
| Measure | Description | Time Frame |
|---|---|---|
| Voice-Vibratory Assessment With Laryngeal Imaging | exploratory measure | up to 5 weeks after baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Bonilha, PhD | Medical University of South Carolina | Principal Investigator |
| Maude Desjardins, M.Sc. | Medical University of South Carolina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29403 | United States |
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We had 22 subjects enrolled, however one did not meet the screening requirements and was not further included in the study (and therefore was not randomized to an intervention group). Another participant withdrew before being randomized to an intervention group. In total, 20 participants were randomized to the intervention groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inspiratory Muscle Strength Training | The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST). |
| FG001 | Expiratory Muscle Strength Training | The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST). |
| FG002 | Voice Exercises | 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. Voice Exercises: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Considering the pilot data of the study, the study team enrolled even participants who would not be able to complete the study protocol because of transportation burden. However, the study team considered only participants who COMMITTED to the whole protocol for baseline and results analysis. Only data for those subjects are presented here.
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| ID | Title | Description |
|---|---|---|
| BG000 | Inspiratory Muscle Strength Training | The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST). |
| BG001 | Expiratory Muscle Strength Training |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 ) | Per protocol | Posted | Mean | Standard Deviation | score on a scale | up to 5 weeks after baseline |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inspiratory Muscle Strength Training | The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | The participant reported the presence of marks on the lips that seemed to have been caused by the mouthpiece of the muscle pressure meter, potentially because of a sucking effect during inspiratory muscle strength testing. The marks were temporary. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heather Shaw Bonilha | Medical University of South Carolina | 843-792-2527 | bonilhah@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2019 | Jun 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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Perceptual ratings of voice quality and of videostroboscopic images of the larynx will be rater by external judges, who will be blinded to the group assignment and to the assessment time (pre or post treatment).
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| 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. |
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| 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. |
|
Acoustic measure of voice quality, in Decibels
| 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. | up to 5 weeks after baseline |
| Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ) | Acoustic measure of voice quality, expressed as a percentage | 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). | 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. | 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). | 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). | up to 5 weeks after baseline |
| Post-treatment Mean in Average Glottal Airflow | Aerodynamic measure of voice expressed in Liters/second | up to 5 weeks after baseline |
| Post-treatment Mean in Average Subglottal Pressure | Aerodynamic measure of voice expressed in cmH20 | 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 | up to 5 weeks after baseline |
| Post-treatment Mean in Maximum Expiratory Pressure (MEP) | Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20 | up to 5 weeks after baseline |
| Post-treatment Mean in Maximum Inspiratory Pressure (MIP) | Indirect measure of respiratory muscle strength, expressed in cmH20 | up to 5 weeks after baseline |
| Post-treatment Mean in Forced Vital Capacity (FVC) | Measure of pulmonary function, expressed as a percent predicted value | 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 | 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) | up to 5 weeks after baseline |
The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).
| BG002 | Voice Exercises | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Reflux Symptom Index score | The Reflux Symptom Index score can range from 0 to 45, with a lower score considered a more favorable outcome. A score greater than 13 is associated with a reflux-related issue. | Mean | Standard Deviation | Score on a scale |
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| Voice Handicap Index score | The Voice Handicap Index score can range from 0 to 40, with a lower score being more favorable. A score greater than 11 is indicative of a voice-related handicap. | Mean | Standard Deviation | Score on a scale |
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| OG002 | Voice Exercises | 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. |
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| Secondary | Post-treatment Mean in (Habitual) Sound Pressure Level | Acoustic measure of loudness, in Decibels | Per protocol | Posted | Mean | Standard Deviation | Decibels (dB) | up to 5 weeks after baseline |
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| Secondary | Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading) | Acoustic measure of voice quality, in Decibels | Per protocol | Posted | Mean | Standard Deviation | Decibels (dB) | up to 5 weeks after baseline |
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| Secondary | 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. | Per protocol | Posted | Mean | Standard Deviation | ratio | up to 5 weeks after baseline |
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| Secondary | Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ) | Acoustic measure of voice quality, expressed as a percentage | Per protocol | Posted | Mean | Standard Deviation | percentage | up to 5 weeks after baseline |
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| Secondary | 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). | Per protocol | Posted | Mean | Standard Deviation | units on a scale | up to 5 weeks after baseline |
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| Secondary | 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. | Per protocol | Posted | Mean | Standard Deviation | Index | up to 5 weeks after baseline |
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| Secondary | 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). | Per protocol | Posted | Mean | Standard Deviation | score on a scale | up to 5 weeks after baseline |
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| Secondary | 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). | Per protocol | Posted | Mean | Standard Deviation | score on a scale | up to 5 weeks after baseline |
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| Secondary | Post-treatment Mean in Average Glottal Airflow | Aerodynamic measure of voice expressed in Liters/second | Per protocol | Posted | Mean | Standard Deviation | liters/second | up to 5 weeks after baseline |
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| Secondary | Post-treatment Mean in Average Subglottal Pressure | Aerodynamic measure of voice expressed in cmH20 | Per protocol | Posted | Mean | Standard Deviation | cmH20 | up to 5 weeks after baseline |
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| Secondary | Post-treatment Mean in Aerodynamic Resistance | Aerodynamic measure (subglottal pressure divided by mean flow rate), expressed as cmH20/liters/second | Per protocol | Posted | Mean | Standard Deviation | cmH20/liters/second | up to 5 weeks after baseline |
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| Secondary | Post-treatment Mean in Maximum Expiratory Pressure (MEP) | Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20 | Per protocol | Posted | Mean | Standard Deviation | cmH20 | up to 5 weeks after baseline |
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| Secondary | Post-treatment Mean in Maximum Inspiratory Pressure (MIP) | Indirect measure of respiratory muscle strength, expressed in cmH20 | Per protocol | Posted | Mean | Standard Deviation | cmH20 | up to 5 weeks after baseline |
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| Secondary | Post-treatment Mean in Forced Vital Capacity (FVC) | Measure of pulmonary function, expressed as a percent predicted value | Per protocol | Posted | Mean | Standard Deviation | percentage of predicted value | up to 5 weeks after baseline |
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| Secondary | Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1) | Measure of pulmonary function expressed as percent predicted value | Per protocol | Posted | Mean | Standard Deviation | percentage of predicted value | up to 5 weeks after baseline |
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| Secondary | 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) | Per protocol | Posted | Mean | Standard Deviation | percentage of predicted value | up to 5 weeks after baseline |
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| Other Pre-specified | Voice-Vibratory Assessment With Laryngeal Imaging | exploratory measure | Not Posted | up to 5 weeks after baseline | Participants |
| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Expiratory Muscle Strength Training | The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST). | 0 | 7 | 0 | 7 | 1 | 7 |
| EG002 | Voice Exercises | 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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| Transient aching | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | One participant reported transient aching in the ribcage after doing IMST. The participant's aching resolved. The study team lowered the load on the device and the participant was told to stop the exercises if feeling any aching. |
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| D026741 |
| Physical Therapy Modalities |