Muscle Tension DysphoniaNCT04710862
The Effects of Respiratory Training on Voice
A study testing Breathing training without a device and Breathing training with a device in people with Muscle Tension Dysphonia, run by Syracuse University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Tension Dysphonia
- What is being tested?
- Breathing training without a device and Breathing training with a device
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2021to 23 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 or older
- Self-report of general good health other than voice disorder
- Self-report of normal pulmonary function
- Non-smoker status for at least the last 5 years
- English as their primary language to avoid potential linguistically-based differences in acoustic measures of voice
- Adequate visual acuity (with or without corrective lenses) to read basic graphs and print, as determined with visual screening
Show all 21Show fewer
- No evidence of current organic or neurologic laryngeal pathology, as assessed by nasolaryngoscopy examination and reviewed by a laryngologist
- No prior surgery to the vocal folds
- Do not report difficulty with swallowing
- Not currently receiving voice therapy or other voice treatment that cannot be discontinued
- Do not report a bilateral, severe to profound hearing loss
- Willingness to be recorded for data collection that is necessary for this study
- Have a confirming diagnosis of Muscle Tension Dysphonia from an otolaryngologist and speech-language pathologist
- Demonstrate quantified auditory-perceptual dysphonia and acoustic dysphonia (Cepstral/Spectral Index of Dysphonia) that exceed normative values for the participant's age and sex
- Based on the nasolaryngoscopy examination and assessment performed by the otolaryngologist, show one or more patterns of supraglottic activity that are consistent with adducted vocal fold hyperfunction
- Show no evidence of abnormal, incomplete vocal fold closure patterns as determined on the videostroboscopy assessment (patterns of posterior glottal gaps are normal and expected)
- Show no evidence of additional neurological voice disorders such as spasmodic dysphonia or vocal fold paralysis
- Show elevated hyolaryngeal position that exceeds normative expectations as determined through quantitative analysis of ultrasonographic laryngeal images measuring change from rest to phonation
- Demonstrate voice problems that have persisted for ≥2 months
- Demonstrate self-reported increase in speaking effort
- Show evidence of speech breathing abnormalities relative to accepted normative values
Who cannot join
- Ages 17 or younger
- Self-report of major health problems
- Self-report of pulmonary disease such as asthma, chronic obstructive pulmonary disease, or emphysema
- Current smoker status or prior smoker status within the last 5 years
- English not the primary language
- Inadequate visual acuity (with corrective lenses if applicable) to read basic graphs and print as determined by failing a visual screening
Show all 20Show fewer
- Evidence of current organic or neurologic laryngeal pathology, as assessed by nasolaryngoscopy examination and reviewed by a laryngologist
- Prior surgery to the vocal folds
- Currently receiving voice therapy or other voice treatment that cannot be discontinued
- Self-report of a bilateral, severe to profound hearing loss
- Not willing to be recorded for data collection that is necessary for this study
- No confirming diagnosis of Muscle Tension Dysphonia from an otolaryngologist and speech-language pathologist
- Do not demonstrate quantified auditory-perceptual dysphonia and acoustic dysphonia (Cepstral/Spectral Index of Dysphonia) that exceed normative values for the participant's age and sex
- Based on the nasolaryngoscopy examination and assessment performed by the otolaryngologist, do not show one or more patterns of supraglottic activity that are consistent with adducted vocal fold hyperfunction
- Show evidence of abnormal, incomplete vocal fold closure patterns as determined on the videostroboscopy assessment (patterns of posterior glottal gaps are normal and expected)
- Show evidence of additional neurological voice disorders such as spasmodic dysphonia or vocal fold paralysis
- Do not show elevated hyolaryngeal position that exceeds normative expectations as determined through quantitative analysis of ultrasonographic laryngeal images measuring change from rest to phonation
- Demonstrate voice problems that have persisted for less than 2 months
- Do not demonstrate self-reported increase in speaking effort
- Do not show evidence of speech breathing abnormalities relative to accepted normative values
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Respiratory-Based Treatment for Muscle Tension Dysphonia: A Randomized Controlled Trial
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.
- Conditions
- Muscle Tension Dysphonia
- Being tested
- Breathing training without a device, Breathing training with a device
- Keywords
- voice, voice disorder, treatment, respiratory, muscle tension dysphonia, training
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing training without a deviceBehavioural
Breathing training without a mouth device
Breathing training with a deviceBehavioural
Breathing training with a mouth device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Breathing training with a device |
| 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. Receives: Behavioral: Breathing training without a device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
Secondary outcomes (2)
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.
Measured: 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.
Measured: Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start12 May 2021
- Primary completion29 Aug 2024
- Study completion23 Sep 2024
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 Muscle Tension DysphoniaStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned to one of two conditions
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soren Lowell, Syracuse University
- Investigators
- Soren Y Lowell, PhD, Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710862
- Sponsor's protocol ID
- 20-132
- Status last verified
- Jul 2025
- First submitted
- 30 Nov 2020
- Last updated
- 24 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Respiratory-Based Treatment for Muscle Tension Dysphonia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04710862
- Acronym / sponsor ID
- 20-132
- Conditions
- Muscle Tension Dysphonia
- Keywords
- voice, voice disorder, treatment, respiratory, muscle tension dysphonia, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Posted 24 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two conditions
| Arm | Type | Receives |
|---|---|---|
| Breathing training with a device (Sham Training as Control) | Active comparator | Behavioral: Breathing training with a deviceRespiratory 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 | Behavioral: Breathing training without a deviceRespiratory 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Ages 18 or older
- Self-report of general good health other than voice disorder
- Self-report of normal pulmonary function
- Non-smoker status for at least the last 5 years
- English as their primary language to avoid potential linguistically-based differences in acoustic measures of voice
Key exclusion criteria (20 listed)
- Ages 17 or younger
- Self-report of major health problems
- Self-report of pulmonary disease such as asthma, chronic obstructive pulmonary disease, or emphysema
- Current smoker status or prior smoker status within the last 5 years
- English not the primary language
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 |
|---|---|---|
| Breathing training without a deviceBreathing training without a mouth device | Behavioural | Breathing training without a device (Respiratory Lung Volume Training) |
| Breathing training with a deviceBreathing training with a mouth device | Behavioural | Breathing training with a device (Sham Training as Control) |
Primary outcome
Post Training Lung Volume Initiation
Time frame: Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
Average level of lung volume at which speech breaths are initiated, expressed in percent vital capacity relative to resting expiratory level.
Post Training Lung Volume Termination
Time frame: Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity relative to resting expiratory level.
Post Training Lung Volume Excursion
Time frame: Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity.
Post Training Cepstral Peak Prominence
Time frame: Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
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.
Post Training Cepstral/Spectral Index of Dysphonia
Time frame: Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
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.
2 secondary outcomes
Post Training Auditory-Perceptual Overall Severity of Voice Disorder
Time frame: Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
Post Training Voice Handicap Index-10
Time frame: Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Muscle Tension Dysphonia
RecruitingEarly Phase 1
Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction
Voice Disorders, Vocal Fold Polyp
Recruiting
Voice Therapy Per the Rehabilitation Treatment Specification System
Muscle Tension Dysphonia
RecruitingObservational study
Imaging Genetics of Laryngeal Dystonia
Laryngeal Dystonia, Unaffected Relatives of Laryngeal Dystonia Patients
Recruiting
Deconstructing Voice Therapy: Towards Enhanced Communication Outcomes
Dysphonia, Primary Muscle Tension Dysphonia (MTD)
RecruitingPhase 3
Translaryngeal Vibration for Hyperfunctional Voice Disorders
Dysphonia, Muscle Tension 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.
Soren Y Lowell, PhD principal investigator
Syracuse University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing training without a device and Breathing training with a device in people with Muscle Tension Dysphonia, run by Syracuse University 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 21 inclusion and 20 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 24 Jul 2025. 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 24 Jul 2025). 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 Training Lung Volume Initiation (time frame: Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment). The study lists 5 primary outcomes in all. 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 24 Jul 2025.