Spots Global Cancer Trial Database for SpeakFree Heat and Moisture Exchanger (HME)
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Trial Identification
Brief Title: SpeakFree Heat and Moisture Exchanger (HME)
Official Title: Evaluation of a Disposable Hands-Free Heat and Moisture Exchanger (HME) Valve: The Blom-Singer SpeakFree HME Hands Free Valve
Study ID: NCT05349487
Study Description
Brief 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).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Miami, Miami, Florida, United States
Contact Details
Name: Mario A Landera, SLP.D.
Affiliation: University of Miami
Role: PRINCIPAL_INVESTIGATOR
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