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NCT05349487 · ClinicalTrials.gov registry record · NA
SpeakFree Heat and Moisture Exchanger (HME)
A NA study, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT05349487 is a NA study that has completed, run by University of Miami. The registered enrollment target is 18 participants.
The verdict
NCT05349487, a NA study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
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).
Interventions
- DEVICE SpeakFree HME Hands Free Valve
- OTHER Digital Occlusion
- DEVICE Digital Depression HME
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-06-28 |
| Est. Completion | 2025-01-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05349487
The ClinicalTrials.gov registry entry for NCT05349487 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which SpeakFree HME Hands Free Valve is the first listed.
NCT05349487 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05349487 about?
NCT05349487 is a clinical study titled "SpeakFree Heat and Moisture Exchanger (HME)". 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 ...
What is the current status of trial NCT05349487?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2022-06-28. Estimated completion is 2025-01-30.
What interventions are being tested in trial NCT05349487?
The interventions under investigation include: SpeakFree HME Hands Free Valve (DEVICE), Digital Occlusion (OTHER), Digital Depression HME (DEVICE).
Who is sponsoring clinical trial NCT05349487?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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