The Effects of Respiratory Training on Voice

Sponsor

Syracuse University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04710862

Collaborator

(none)

Enrollment

Location

Arms

27.6

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Tension Dysphonia	Behavioral: Breathing training without a device Behavioral: Breathing training with a device	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly assigned to one of two conditionsParticipants will be randomly assigned to one of two conditions

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 12, 2021

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Breathing training with a device 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 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

Arm

Intervention/Treatment

Active Comparator: Breathing training with a device

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 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

Outcome Measures

Primary Outcome Measures

Change in Lung Volume Initiation [Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.]
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 [Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.]
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 [Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.]
Average level of lung volume at which speech breaths are terminated, expressed in percent vital capacity.
Change in Cepstral Peak Prominence [Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.]
Average energy in first cepstral peak relative to overall cepstral energy, measured in cepstral decibels
Change in Cepstral/Spectral Index of Dysphonia [Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.]
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 [Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.]
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 [Assessed during initial baseline testing and approximately 7 weeks later directly after training completion.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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