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Completed

NCT Number: NCT04710862

The Effects of Respiratory Training on Voice

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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Key information

Conditions

Muscle Tension Dysphonia Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Voice Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syracuse University

Syracuse, New York, 13244, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breathing training without a device

Behavioral

Breathing training without a mouth device

Breathing training with a device

Behavioral

Breathing training with a mouth device

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Syracuse University

Other

Registry information

Official study title

The Effects of Respiratory-Based Treatment for Muscle Tension Dysphonia: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 15, 2021
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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