NCT05349487

SpeakFree Heat and Moisture Exchanger (HME)

Evaluation of a Disposable Hands-Free Heat and Moisture Exchanger (HME) Valve: The Blom-Singer SpeakFree HME Hands Free Valve

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Laryngeal Cancer
• Laryngectomy

Interventions

Type	Name	Description
DEVICE	SpeakFree HME Hands Free Valve	A voice prosthesis, SpeakFree HME Hands Free Valve, achieved with creation of a tracheoesophageal puncture will be placed over the stoma for 1 month.
OTHER	Digital Occlusion	Using participant's own fingers, they will be putting their fingers over the stoma.
DEVICE	Digital Depression HME	A digital handheld press-down HME will be placed over stoma.

Timeline

• Start date: 2022-06-28
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2022-04-27
• Last updated: 2025-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study