search
Back to results

The Effects of Respiratory Training on Voice

Primary Purpose

Muscle Tension Dysphonia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathing training without a device
Breathing training with a device
Sponsored by
Syracuse University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Tension Dysphonia focused on measuring voice, voice disorder, treatment, respiratory, muscle tension dysphonia, training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Syracuse UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Breathing training with a device

Breathing training without a device

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Lung Volume Initiation
Average level of lung volume at which speech breaths are initiated, expressed in percent vital capacity relative to resting expiratory level.
Change in Lung Volume Termination
Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity relative to resting expiratory level.
Change in Lung Volume Excursion
Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity.
Change in Cepstral Peak Prominence
Average energy in first cepstral peak relative to overall cepstral energy, measured in cepstral decibels
Change in Cepstral/Spectral Index of Dysphonia
Average multivariate measure of spectral and cepstral voice features that reflects the amount of acoustic voice disorder severity.

Secondary Outcome Measures

Change in Auditory-Perceptual Overall Severity of Voice Disorder
Listener-rated assessment of overall voice disorder severity on a 0-100 millimeter visual analog scale. The minimum value is 0 and the maximum value is 100 on this scale. Higher scores mean greater voice disorder severity.
Change in Voice Handicap Index-10
Participant self-ratings of the impact and disability of the voice disorder. The Voice Handicap Index-10 is a rating scale questionnaire with 10 questions, each scored on a scale of 0 (Never happens) to 4 (Always happens). Higher scores mean greater handicap and disability from the voice disorder.

Full Information

First Posted
November 30, 2020
Last Updated
September 9, 2023
Sponsor
Syracuse University
search

1. Study Identification

Unique Protocol Identification Number
NCT04710862
Brief Title
The Effects of Respiratory Training on Voice
Official Title
The Effects of Respiratory-Based Treatment for Muscle Tension Dysphonia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Syracuse University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tension Dysphonia
Keywords
voice, voice disorder, treatment, respiratory, muscle tension dysphonia, training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to one of two conditions
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breathing training with a device
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Breathing training without a device
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Breathing training without a device
Intervention Description
Breathing training without a mouth device
Intervention Type
Behavioral
Intervention Name(s)
Breathing training with a device
Intervention Description
Breathing training with a mouth device
Primary Outcome Measure Information:
Title
Change in Lung Volume Initiation
Description
Average level of lung volume at which speech breaths are initiated, expressed in percent vital capacity relative to resting expiratory level.
Time Frame
Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.
Title
Change in Lung Volume Termination
Description
Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity relative to resting expiratory level.
Time Frame
Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.
Title
Change in Lung Volume Excursion
Description
Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity.
Time Frame
Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.
Title
Change in Cepstral Peak Prominence
Description
Average energy in first cepstral peak relative to overall cepstral energy, measured in cepstral decibels
Time Frame
Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.
Title
Change in Cepstral/Spectral Index of Dysphonia
Description
Average multivariate measure of spectral and cepstral voice features that reflects the amount of acoustic voice disorder severity.
Time Frame
Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.
Secondary Outcome Measure Information:
Title
Change in Auditory-Perceptual Overall Severity of Voice Disorder
Description
Listener-rated assessment of overall voice disorder severity on a 0-100 millimeter visual analog scale. The minimum value is 0 and the maximum value is 100 on this scale. Higher scores mean greater voice disorder severity.
Time Frame
Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.
Title
Change in Voice Handicap Index-10
Description
Participant self-ratings of the impact and disability of the voice disorder. The Voice Handicap Index-10 is a rating scale questionnaire with 10 questions, each scored on a scale of 0 (Never happens) to 4 (Always happens). Higher scores mean greater handicap and disability from the voice disorder.
Time Frame
Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soren Y Lowell, PhD
Phone
3154439648
Email
slowell@syr.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soren Y Lowell, PhD
Organizational Affiliation
Syracuse University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syracuse University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soren Y Lowell, PhD
Phone
315-443-9648
Email
slowell@syr.edu

12. IPD Sharing Statement

Learn more about this trial

The Effects of Respiratory Training on Voice

We'll reach out to this number within 24 hrs