The Effects of Respiratory Training on Voice

July 3, 2025 updated by: Soren Lowell, Syracuse University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Soren Y Lowell, PhD
  • Phone Number: 3154439648
  • Email: slowell@syr.edu

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13244
        • Syracuse University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Behavioral: Breathing training with a device
Breathing training with a mouth device
Active Comparator: 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.
Behavioral: Breathing training without a device
Breathing training without a mouth device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
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.
Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
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.
Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
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.
Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment
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.
Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Syracuse University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Soren Y Lowell, PhD, Syracuse University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-132

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Muscle Tension Dysphonia

Clinical Trials on Breathing training with a device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings