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PhoRTE + EMST for Voice Disorders

N/A
Waitlist Available
Led By Amanda Gillespie
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at each study visit through study completion; time 0 (therapy visit 1-baseline), follow-up week 1 (therapy visit 2), follow-up week 2 (therapy visit 3),follow-up week 3 (therapy visit 4), follow-up week 5 (follow up visit)
Awards & highlights

Study Summary

The larynx and vocal folds undergo many age-related changes in their physiology and structure that can lead to undesirable effects on the voice, with changes in the respiratory system compounding these deficits. These changes, also called presbyphonia, can have serious detrimental effects on the lives of elderly individuals. There are few studies that have evaluated the use of voice therapy treatment options for these patients. The primary aim of this study is to test whether the addition of expiratory muscle strength training (EMST) to a current, validated voice therapy protocol aimed at treating presbyphonia, (phonation resistance training, PhoRTE) can improve outcomes of therapy.

Eligible Conditions
  • Voice Disorders
  • Vocal Cord Atrophy
  • Age-Related Voice Change

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at each study visit through study completion; time 0 (therapy visit 1-baseline), follow-up week 1 (therapy visit 2), follow-up week 2 (therapy visit 3),follow-up week 3 (therapy visit 4), follow-up week 5 (follow up visit)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at each study visit through study completion; time 0 (therapy visit 1-baseline), follow-up week 1 (therapy visit 2), follow-up week 2 (therapy visit 3),follow-up week 3 (therapy visit 4), follow-up week 5 (follow up visit) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Voice Handicap Index-10 (VHI-10) Score
Secondary outcome measures
AVI Score at Baseline and Follow up (5 Weeks)
Cepstral Peak Prominence (CPP) Fundamental Frequency (F0) at Baseline and Follow up (5 Weeks)
Cepstral Peak Prominence at Baseline and 5 Weeks Follow up
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PhoRTE + EMSTExperimental Treatment2 Interventions
This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
Group II: PhoRTEActive Control1 Intervention
This group will undergo standard PhoRTE therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EMST
2009
Completed Phase 3
~110

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,655 Previous Clinical Trials
2,572,459 Total Patients Enrolled
2 Trials studying Voice Disorders
157 Patients Enrolled for Voice Disorders
Amanda GillespiePrincipal InvestigatorEmory University
~4 spots leftby Jul 2025
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