The purpose of the study is to evaluate the new Blom-Singer SpeakFree disposable hands free valve heat and moisture exchanger (HME). The investigators will compare the SpeakFree to other modalities of stomal occlusion (digital occlusion and digital depression of an HME) for patients who communicate with a voice prosthesis as determined by patient preference and satisfaction. In addition, the investigators will compare the SpeakFree to other modalities of stomal occlusion as determined by objective measures of speech and voice parameters (maximum phonation time, syllables per breath, minimum/maximum phonation pressures, and a clinician rating of voice quality using a visual analog scale).
Who can participate
Age range
18 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:
* Participants who have undergone a total laryngectomy who have and use a voice prosthesis as their primary form of communication for at least 3 months prior to study enrollment.
* Participants must have had at least 2 voice prosthesis management visits from a speech pathologist at the University of Miami prior to study enrollment.
* Participants must have fully healed suture lines.
* Participants must demonstrate fluent tracheoesophageal speech (i.e., maximum phonation time of at least 5 seconds during 3 consecutive trials)
* Current HME use for a minimum of 1 month
* Participants willing to complete the survey and provide a signed Informed Consent Form
* Males and non-pregnant females over the age of 18
Exclusion Criteria:
* Participants who do not have a voice prosthesis.
* Participants who have dysarthria.
* Participants who are currently receiving treatment for head and neck cancer.
* Participants who have an underlying neurologic condition potentially impacting speech.
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.