The Effects of Respiratory Training on Voice

NCT04710862 | Completed Results

• 1 other identifier: 20-132
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

voice; voice disorder; treatment; respiratory; muscle tension dysphonia; training

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment

• Post Training Voice Handicap Index-10

  Assessed after completion of 6-week training period, approximately 7 weeks after baseline assessment

Study Arms (2)

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.

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.

Behavioral: Breathing training without a device

Interventions

Breathing training without a device BEHAVIORAL

Breathing training without a mouth device

Breathing training without a device (Respiratory Lung Volume Training)

Breathing training with a device BEHAVIORAL

Breathing training with a mouth device

Breathing training with a device (Sham Training as Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Syracuse University: lead

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

Location

MeSH Terms

Conditions

Voice Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Soren Lowell
• Organization: Syracuse University

slowell@syr.edu

315-443-9615

Study Officials

• Soren Y Lowell, PhD

  Syracuse University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to one of two conditions

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: January 15, 2021
• Study Start: May 12, 2021
• Primary Completion: August 29, 2024
• Study Completion: September 23, 2024
• Last Updated: July 24, 2025
• Results First Posted: July 24, 2025

Record last verified: 2025-07

Locations

US (1)