An interventional study of Breathing training without a device and Breathing training with a device in Muscle Tension Dysphonia, sponsored by Syracuse University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Syracuse University · Not applicable, Interventional, and Treatment
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.
77 studies on the registry are indexed under Voice Disorders; 17 are open to participants now.
This study's enrollment of 27 is below the median of 41 across 54 interventional studies indexed under Voice Disorders.
Browse Voice Disorders studies →Syracuse University is the lead sponsor of 33 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Breathing training with 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.
Behavioral: Breathing training without a device
Breathing training without a mouth device
Breathing training with a mouth device
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
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.
Time frame: 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.
Time frame: Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
| Milestone | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
Average level of lung volume at which speech breaths are initiated, expressed in percent vital capacity relative to resting expiratory level.
| % vital capacity relative to rest level | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) |
|---|---|---|
| Post Training Lung Volume Initiation | 21.07 ± 4.94 | 27.04 ± 7.71 |
Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity relative to resting expiratory level.
| % vital capacity relative to rest level | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) |
|---|---|---|
| Post Training Lung Volume Termination | -0.44 ± 5.26 | 2.29 ± 5.04 |
Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity.
| % vital capacity | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) |
|---|---|---|
| Post Training Lung Volume Excursion | 21.51 ± 4.81 | 24.74 ± 6.48 |
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.
| decibels (dB) | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) |
|---|---|---|
| Post Training Cepstral Peak Prominence | 4.86 ± 1.10 | 5.31 ± 0.81 |
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.
| units on a scale | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) |
|---|---|---|
| Post Training Cepstral/Spectral Index of Dysphonia | 29.03 ± 14.06 | 21.96 ± 9.76 |
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.
| units on a scale | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) |
|---|---|---|
| Post Training Auditory-Perceptual Overall Severity of Voice Disorder | 33.29 ± 24.18 | 18.78 ± 12.28 |
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.
| units on a scale | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) |
|---|---|---|
| Post Training Voice Handicap Index-10 | 14.38 ± 6.63 | 12.13 ± 6.02 |
Collected over Adverse event data were collected over the period in which each participant completed baseline testing, training, and post-testing, or 8 weeks total.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Breathing Training With a Device (Sham Training as Control) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Breathing Training Without a Device (Respiratory Lung Volume Training) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) | Total |
|---|---|---|---|
| Mean | 60.0 ± 15.4 | 55.4 ± 12.6 | 58.3 ± 13.9 |
| Sex: Female, Male(Participants) | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) | Total |
|---|---|---|---|
| Female | 7 | 5 | 12 |
| Male | 5 | 7 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 12 | 11 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 12 | 11 | 23 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
| Lung Volume Initiation - Relative to Resting Expiratory Level(% vital capacity relative to rest level) | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) | Total |
|---|---|---|---|
| Mean | 19.01 ± 6.11 | 15.05 ± 7.00 | 17.03 ± 6.56 |
| Lung Volume Termination - Relative to Resting Expiratory Level(% vital capacity relative to rest level) | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) | Total |
|---|---|---|---|
| Mean | -1.07 ± 4.40 | -4.55 ± 5.38 | -2.81 ± 4.89 |
| Lung Volume Excursion(% vital capacity relative to rest level) | Breathing Training With a Device (Sham Training as Control) | Breathing Training Without a Device (Respiratory Lung Volume Training) | Total |
|---|---|---|---|
| Mean | 20.08 ± 4.94 | 19.60 ± 8.04 | 19.84 ± 6.49 |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2021 to primary completion in Aug 2024, 39 months.
Results were first posted in Jul 2025, 10 months after primary completion.
Of 30 interventional studies with no phase under Voice Disorders, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's 39 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Syracuse University