The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

NCT03692494 | Withdrawn

• 1 other identifier: 20171103
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate if adding expiratory muscle strength training to traditional voice therapy for individuals with dysphonia due to glottal insufficiency improves maximal expiratory pressure, acoustic and aerodynamic measures (i.e. amplitude, maximum phonation time, peak expiratory flow), and voice related quality of life.

Conditions

Dysphonia; Unilateral Vocal Cord Paralysis

Outcome Measures

Primary Outcomes (2)

• Maximum expiratory pressure

  Maximum expiratory pressure, in cm of H2O, will be measured to evaluate how much pressure a participant can blow into a respiratory pressure meter.

  16 weeks

• Amplitude

  Amplitude of voice, in decibels, will be measured using Voice Range Profile on Kay Pentax CSL and will be compared to gender matched normative values for normal and loud volumes.

  16 weeks

Secondary Outcomes (7)

• Fundamental frequency

  16 weeks

• Dynamic pitch range

  16 weeks

• Cepstral Peak Prominence (CPP)

  16 weeks

• Cepstral spectral index of dysphonia (CSID)

  16 weeks

• Voice Handicap Index

  16 weeks

Study Arms (3)

Unilateral vocal fold paralysis standard of care voice therapy

EXPERIMENTAL

The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques.

Other: Standard of care voice therapy

Unilateral paralysis standard of care voice therapy plus EMST

EXPERIMENTAL

The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. EMST consists of blowing into respiratory device at a measure threshold pressure. As strength improves threshold resistance will be increased.

Other: Standard of care voice therapy; Other: Expiratory muscle strength training (EMST)

Parkinson's disease standard of care voice therapy plus EMST

EXPERIMENTAL

The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. EMST consists of blowing into respiratory device at a measure threshold pressure. As strength improves threshold resistance will be increased.

Other: Standard of care voice therapy; Other: Expiratory muscle strength training (EMST)

Interventions

Standard of care voice therapy OTHER

Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder

Parkinson's disease standard of care voice therapy plus EMST; Unilateral paralysis standard of care voice therapy plus EMST; Unilateral vocal fold paralysis standard of care voice therapy

Expiratory muscle strength training (EMST) OTHER

EMST150 used at 75% of their maximum expiratory pressure. Participants will be directed to perform 5 sets of 5 breaths, 5 days per week, for 5 weeks, at the pressure threshold established in therapy. Maximum expiratory pressure will then be determined at the beginning of each therapy session and recalibration of the device will be performed if indicated.

Parkinson's disease standard of care voice therapy plus EMST; Unilateral paralysis standard of care voice therapy plus EMST

Eligibility Criteria

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

You may qualify if:

• Individuals with glottic insufficiency.
• Adequate cognition evidenced by score of 24 or higher on the Mini-Mental State Examination (MMSE) survey to determine if the subject has the mental capacity to participate in therapy
• Completed voice combination evaluation with speech pathologists and otolaryngologist.
• Individuals 18 years of age or older

You may not qualify if:

• Adults unable to consent
• Non English or Spanish speakers
• Pregnant women
• Prisoners
• Individuals with significant uncontrolled chronic and progressive respiratory diseases including COPD, interstitial lung disease, and cystic fibrosis.
• Individuals with uncontrolled blood pressure.
• Individuals with significant GI disease and/or gastroesophageal surgery with the exception of well-controlled GERD.
• Individuals with a history of abdominal hernia.
• Individuals with difficulty complying due to neuropsychological dysfunction (e.g., severe depression, psychosis).
• Individuals with other neurological disorders and/or neuromuscular disease other than Parkinson's Disease

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Dysphonia; Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vagus Nerve Diseases; Cranial Nerve Diseases; Paralysis

Study Officials

• Adam T Lloyd, SLP-D, MM, MA

  University of Miami

  PRINCIPAL INVESTIGATOR

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: Speech Pathologist

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 2, 2018
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)