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NCT03557775 · ClinicalTrials.gov registry record · NA
Respiratory Muscle Strength Training in Presbyphonia
A NA study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT03557775 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 22 participants.
The verdict
NCT03557775, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
Presbyphonia is an age-related voice disorder that affects more than 10 million people in the United States. Presbyphonia is characterized by vocal fold atrophy that impairs older individuals' ability to communicate, leading to social isolation and reduced quality of life. Outcomes from current treatment approaches are often suboptimal for patients with presbyphonia as they do not sufficiently challenge the respiratory system to induce meaningful change. It is highly likely that the addition of respiratory training would result in greatly improved outcomes, such as the ability to speak loud and long enough to have a normal conversation. The purpose of this study will be to examine the effect of adding inspiratory muscle strength training (IMST) or expiratory muscle strength training (EMST) to standard of care voice therapy on respiratory and voice outcomes in patients with an age-related voice disorder. Forty-eight participants diagnosed with presbyphonia will be blocked-randomized into three intervention groups, using a 3-parallel arm design: IMST and voice exercises, EMST and voice exercises, and voice exercises during all session. Study endpoints will be the change in voice and respiratory measures after four treatment sessions compared to baseline values. Response to treatment will be analyzed to determine if there are subgroups of high- or low-responders based on baseline voice and respiratory characteristics.
Interventions
- BEHAVIORAL Voice Exercises
- DEVICE Inspiratory Muscle Strength Training (IMST)
- DEVICE Expiratory Muscle Strength Training (EMST)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2019-07-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03557775
The ClinicalTrials.gov registry entry for NCT03557775 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Voice Exercises is the first listed.
NCT03557775 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03557775 about?
NCT03557775 is a clinical study titled "Respiratory Muscle Strength Training in Presbyphonia". Presbyphonia is an age-related voice disorder that affects more than 10 million people in the United States. Presbyphonia is characterized by vocal fold atrophy that impairs older individuals' ability to communicate, leading to social isolation and reduced quality of life. Outcomes from current trea...
What is the current status of trial NCT03557775?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2018-06-15. Estimated completion is 2019-07-16.
What interventions are being tested in trial NCT03557775?
The interventions under investigation include: Voice Exercises (BEHAVIORAL), Inspiratory Muscle Strength Training (IMST) (DEVICE), Expiratory Muscle Strength Training (EMST) (DEVICE).
Who is sponsoring clinical trial NCT03557775?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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