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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: Completed NA study, sponsored by University of Miami.
NCT05349487 is a NA study that has completed, run by University of Miami. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Patient preference and satisfaction will be measured using a visual Analog Scale (VAS) ranging in score from 1-10 with a higher score indicating greater satisfaction with the device.
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 |
What the finished NCT05349487 record still lists
NCT05349487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which SpeakFree HME Hands Free Valve is the first listed.
NCT05349487 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05349487's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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