Respiratory Muscle Strength Training in Presbyphonia (NCT03557775) | Clinical Trial Compass
CompletedNot Applicable
Respiratory Muscle Strength Training in Presbyphonia
United States22 participantsStarted 2018-06-15
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* must receive a diagnosis of presbyphonia by a trained laryngologist. The diagnosis will be given following a visual examination if the observations are consistent with the characteristics of a presbylarynx, as judged by the laryngologist.
* must be 50 years old and older.
Exclusion Criteria:
* has received voice therapy in the past year
* presents with a vocal fold pathology other than presbyphonia
* has a known neurologic or a progressive neuromuscular disease
* has a medical condition that could be aggravated by the experimental intervention, or any condition judged by the physician (Dr. Halstead) as being unsuitable for RMST.
* has dysarthria or a language disorder
* has a hearing loss that is not adequately managed
* has a cognitive disorder that might affect treatment compliance
* is unable to give informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.