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Primary muscle tension dysphonia is a voice disorder that involves excessive and poorly coordinated muscle activity affecting multiple subsystems that are involved in speech production, in the absence of structural or neurologic abnormalities of the larynx. Primary muscle tension dysphonia (MTD) is one of the most common forms of voice disorders, accounting for at least 40% of patients seen in voice clinics. Perceptually the voice sounds hoarse and strained, with reduced loudness and pitch range, and people with MTD find speaking very effortful and fatiguing. The physiological abnormalities that characterize MTD are considered multifactorial, and include over-activity of muscles in and around the larynx, laryngeal constriction patterns, and abnormal speech breathing patterns. However, standard treatment approaches for MTD primarily address laryngeal function, including repositioning of laryngeal structures, reducing activity in the intrinsic and extrinsic laryngeal muscles, and altering vibratory patterns. Although voice improvement may follow these treatments, many people with MTD show recurrence of voice problems after only a few months, and some do not improve with treatment. These findings highlight the need for alternative treatments that address the respiratory contributions to MTD, which directly affect the phonatory system. The goal of this project is to compare the effects of two respiratory-based training conditions in people with MTD. A randomized group design will be implemented to determine the respiratory and acoustic effects of each condition. We will determine the effects of each condition immediately after and then 3 and 6 months after training completion to assess short- and long-term training effects. We propose that respiratory training will have a positive effect on related laryngeal behavior and voice. The proposed project has the potential to substantially advance the evidence-based treatment options for MTD, providing a vital step toward reducing the debilitating effects of this disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breathing training with a device (Sham Training as Control) | Active Comparator | Respiratory intervention delivered once a week for 6 weeks, after two initial baseline testing sessions. Participants will perform exhalation exercises through a breathing device. Homework activities will be assigned. Post-training testing sessions will also be conducted. |
|
| Breathing training without a device (Respiratory Lung Volume Training) | Active Comparator | Respiratory intervention delivered once a week for 6 weeks, after two initial baseline testing sessions. Participants will receive training on the use of breathing techniques without a device, but with visual feedback throughout training. Homework activities will be assigned. Post-training testing sessions will also be conducted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathing training without a device | Behavioral | Breathing training without a mouth device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Training Lung Volume Initiation | Average level of lung volume at which speech breaths are initiated, expressed in percent vital capacity relative to resting expiratory level. | Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
| Post Training Lung Volume Termination | Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity relative to resting expiratory level. | Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
| Post Training Lung Volume Excursion | Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity. | Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
| Post Training Cepstral Peak Prominence | Average energy in first cepstral peak relative to overall cepstral energy, measured in cepstral decibels. The Cepstral Peak Prominence measure indicates the regularity, or periodicity, of the voice, and is calculated from the recorded acoustic voice signal. A low score such as 2.0 indicates lower regularity in the voice, or greater severity of voice disturbance, whereas a higher score indicates greater regularity in the voice, or less severity of voice disturbance. The values of this measure can theoretically range from zero to any positive integer value. | Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
| Post Training Cepstral/Spectral Index of Dysphonia | The Cepstral/Spectral Index of Dysphonia is a multivariate measure that indicates the acoustic severity of voice, and is calculated from the recorded acoustic voice signal. The scale generally ranges from 0 to 100, although negative values and values greater than 100 are possible. A score of zero or a low score indicates no acoustic dysphonia (no voice abnormality) or little dysphonia, whereas a high score or score of 100 indicates high severity or maximal severity of acoustic dysphonia. |
| Measure | Description | Time Frame |
|---|---|---|
| Post Training Auditory-Perceptual Overall Severity of Voice Disorder | Auditory-Perceptual Overall Voice Severity is a measure that indicates the perceptual severity of the voice, and is determined by listeners who rate the overall severity of how the voice sounds on a Visual Analog Scale that ranges from 0 to 100. A score of zero or a low score indicates no or little perceived dysphonia (voice abnormality), whereas a high score or score of 100 indicates high or maximal perceived severity of dysphonia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soren Y Lowell, PhD | Syracuse University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse University | Syracuse | New York | 13244 | United States |
27 participants were enrolled in the study. After initial testing to determine inclusion and exclusion criteria, 3 participants were excluded due to not meeting all inclusion/exclusion criteria. The remaining 24 participants were randomized into the two intervention groups, 12 per group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Breathing Training With a Device (Sham Training as Control) | Respiratory intervention delivered once a week for 6 weeks, after two initial baseline testing sessions. Participants will perform exhalation exercises through a breathing device. Homework activities will be assigned. Post-training testing sessions will also be conducted. Breathing training with a device: Breathing training with a mouth device |
| FG001 | Breathing Training Without a Device | Respiratory intervention delivered once a week for 6 weeks, after two initial baseline testing sessions. Participants will receive training on the use of breathing techniques without a device, but with visual feedback throughout training. Homework activities will be assigned. Post-training testing sessions will also be conducted. Breathing training without a device: Breathing training without a mouth device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Breathing Training With a Device (Sham Training as Control) | Respiratory intervention delivered once a week for 6 weeks, after two initial baseline testing sessions. Participants will perform exhalation exercises through a breathing device. Homework activities will be assigned. Post-training testing sessions will also be conducted. Breathing training with a device: Breathing training with a mouth device |
| 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 Training Lung Volume Initiation | Average level of lung volume at which speech breaths are initiated, expressed in percent vital capacity relative to resting expiratory level. | Posted | Mean | Standard Deviation | % vital capacity relative to rest level | Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
|
Adverse event data were collected over the period in which each participant completed baseline testing, training, and post-testing, or 8 weeks total.
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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 | Breathing Training With a Device (Sham Training as Control) | Respiratory intervention delivered once a week for 6 weeks, after two initial baseline testing sessions. Participants will perform exhalation exercises through a breathing device. Homework activities will be assigned. Post-training testing sessions will also be conducted. Breathing training with a device: Breathing training with a mouth device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Soren Lowell | Syracuse University | 315-443-9615 | slowell@syr.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2025 | May 25, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2025 | May 25, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
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Participants will be randomly assigned to one of two conditions
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| Breathing training with a device | Behavioral | Breathing training with a mouth device |
|
| Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
| Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
| Post Training Voice Handicap Index-10 | The Voice Handicap Index-10 is a questionnaire in which the participant rates the amount of handicap they feel from their voice disorder. Each of 10 questions is rated between a score of 0 (no handicap) to 4 (extreme handicap). Total scores on this questionnaire can range between 0 to 40, with a low score indicating that the participant feels low amounts of handicap or life impact from their voice disorder, whereas a high score indicates that a participant feels high amounts of handicap from their voice disorder. | Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
| BG001 | Breathing Training Without a Device (Respiratory Lung Volume Training) | Respiratory intervention delivered once a week for 6 weeks, after two initial baseline testing sessions. Participants will receive training on the use of breathing techniques without a device, but with visual feedback throughout training. Homework activities will be assigned. Post-training testing sessions will also be conducted. Breathing training without a device: Breathing training without a mouth device |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lung Volume Initiation - Relative to Resting Expiratory Level | Mean | Standard Deviation | % vital capacity relative to rest level |
|
| Lung Volume Termination - Relative to Resting Expiratory Level | Mean | Standard Deviation | % vital capacity relative to rest level |
|
| Lung Volume Excursion | Mean | Standard Deviation | % vital capacity relative to rest level |
|
| % Vital Capacity per Syllable | Mean | Standard Deviation | % vital capacity relative to rest level |
|
| Cepstral/Spectral Index of Dysphonia | The Cepstral/Spectral Index of Dysphonia is a multivariate measure that indicates the acoustic severity of voice, and is calculated from the recorded acoustic voice signal. The scale generally ranges from 0 to 100, although negative values and values greater than 100 are possible. A score of zero or a low score indicates no acoustic dysphonia (no voice abnormality) or little dysphonia, whereas a high score or score of 100 indicates high severity or maximal severity of acoustic dysphonia. | Mean | Standard Deviation | units on a scale |
|
| Cepstral Peak Prominence | The Cepstral Peak Prominence measure indicates the regularity, or periodicity, of the voice, and is calculated from the recorded acoustic voice signal. A low score such as 2.0 indicates lower regularity in the voice, or greater severity of voice disturbance, whereas a higher score indicates greater regularity in the voice, or less severity of voice disturbance. The values of this measure can theoretically range from zero to any positive integer value. | Mean | Standard Deviation | decibels (dB) |
|
| Auditory-Perceptual Overall Voice Severity | Auditory-Perceptual Overall Voice Severity is a measure that indicates the perceptual severity of the voice, and is determined by listeners who rate the overall severity of how the voice sounds on a Visual Analog Scale that ranges from 0 to 100. A score of zero or a low score indicates no or little perceived dysphonia (voice abnormality), whereas a high score or score of 100 indicates high or maximal perceived severity of dysphonia. | Mean | Standard Deviation | units on a scale |
|
| Speaking Effort | Speaking effort is a self-rated measure that indicates how much effort the participant feels while speaking, and is rated on a Visual Analog Scale from 0 (no effort) to 100 (maximal effort). This measure represents the difference of what the participant feels is their typical amount of speaking effort minus their rating of comfortable speaking effort. The range of this difference score is usually between 0 to 100. A low score indicates that the participant feels low amounts of effort while speaking, whereas a high score indicates that a participant feels speaking is very effortful. | Mean | Standard Deviation | units on a scale |
|
| Voice Handicap Index-10 | The Voice Handicap Index-10 is a questionnaire in which the participant rates the amount of handicap they feel from their voice disorder. Each of 10 questions is rated between a score of 0 (no handicap) to 4 (extreme handicap). Total scores on this questionnaire can range between 0 to 40, with a low score indicating that the participant feels low amounts of handicap or life impact from their voice disorder, whereas a high score indicates that a participant feels high amounts of handicap from their voice disorder. | Mean | Standard Deviation | units on a scale |
|
Respiratory intervention delivered once a week for 6 weeks, after two initial baseline testing sessions. Participants will receive training on the use of breathing techniques without a device, but with visual feedback throughout training. Homework activities will be assigned. Post-training testing sessions will also be conducted. Breathing training without a device: Breathing training without a mouth device |
|
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| Primary | Post Training Lung Volume Termination | Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity relative to resting expiratory level. | Posted | Mean | Standard Deviation | % vital capacity relative to rest level | Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
|
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| Primary | Post Training Lung Volume Excursion | Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity. | Posted | Mean | Standard Deviation | % vital capacity | Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
|
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|
| Primary | Post Training Cepstral Peak Prominence | Average energy in first cepstral peak relative to overall cepstral energy, measured in cepstral decibels. The Cepstral Peak Prominence measure indicates the regularity, or periodicity, of the voice, and is calculated from the recorded acoustic voice signal. A low score such as 2.0 indicates lower regularity in the voice, or greater severity of voice disturbance, whereas a higher score indicates greater regularity in the voice, or less severity of voice disturbance. The values of this measure can theoretically range from zero to any positive integer value. | Posted | Mean | Standard Deviation | decibels (dB) | Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
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| Primary | Post Training Cepstral/Spectral Index of Dysphonia | The Cepstral/Spectral Index of Dysphonia is a multivariate measure that indicates the acoustic severity of voice, and is calculated from the recorded acoustic voice signal. The scale generally ranges from 0 to 100, although negative values and values greater than 100 are possible. A score of zero or a low score indicates no acoustic dysphonia (no voice abnormality) or little dysphonia, whereas a high score or score of 100 indicates high severity or maximal severity of acoustic dysphonia. | Posted | Mean | Standard Deviation | units on a scale | Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
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| Secondary | Post Training Auditory-Perceptual Overall Severity of Voice Disorder | Auditory-Perceptual Overall Voice Severity is a measure that indicates the perceptual severity of the voice, and is determined by listeners who rate the overall severity of how the voice sounds on a Visual Analog Scale that ranges from 0 to 100. A score of zero or a low score indicates no or little perceived dysphonia (voice abnormality), whereas a high score or score of 100 indicates high or maximal perceived severity of dysphonia. | Posted | Mean | Standard Deviation | units on a scale | Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
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| Secondary | Post Training Voice Handicap Index-10 | The Voice Handicap Index-10 is a questionnaire in which the participant rates the amount of handicap they feel from their voice disorder. Each of 10 questions is rated between a score of 0 (no handicap) to 4 (extreme handicap). Total scores on this questionnaire can range between 0 to 40, with a low score indicating that the participant feels low amounts of handicap or life impact from their voice disorder, whereas a high score indicates that a participant feels high amounts of handicap from their voice disorder. | Posted | Mean | Standard Deviation | units on a scale | Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Breathing Training Without a Device (Respiratory Lung Volume Training) | Respiratory intervention delivered once a week for 6 weeks, after two initial baseline testing sessions. Participants will receive training on the use of breathing techniques without a device, but with visual feedback throughout training. Homework activities will be assigned. Post-training testing sessions will also be conducted. Breathing training without a device: Breathing training without a mouth device | 0 | 12 | 0 | 12 | 0 | 12 |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |