SpeakFree Heat and Moisture Exchanger (HME)

NCT05349487 | Completed DMC FDA Device

• 1 other identifier: 20210501
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

Laryngeal Cancer; Laryngectomy

Keywords

Stoma; Voice Prosthesis; Total Laryngectomy; Heat and Moisture Exchanger (HME)

Outcome Measures

Primary Outcomes (2)

• Satisfaction as measured by VAS

  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.

  Up to 1 month

• Voice Quality: Patient Rating

  Voice Quality will be measured using a visual Analog Scale ranging in score from 1-10 with a higher score indicating that the patient feels their voice quality is better with the device.

  Up to 1 month

Secondary Outcomes (4)

• Change in Maximum Phonation Time

  Baseline, 1 month

• Change in Syllables Per Breath

  Baseline, 1 month

• Pressure Needed to Phonate

  Baseline

• Change in Voice Quality: Clinician Rating

  Baseline, 1 month

Study Arms (1)

SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group

EXPERIMENTAL

Participants will be fitted to use a hand free HME device over their stoma in order to communicate with a voice prosthesis for one month. The participants will also serve as their own control performing voicing and speech tasks using digital occlusion and digital depression HME.

Device: SpeakFree HME Hands Free Valve; Other: Digital Occlusion; Device: Digital Depression HME

Interventions

SpeakFree HME Hands Free Valve DEVICE

A voice prosthesis, SpeakFree HME Hands Free Valve, achieved with creation of a tracheoesophageal puncture will be placed over the stoma for 1 month.

SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group

Digital Occlusion OTHER

Using participant's own fingers, they will be putting their fingers over the stoma.

SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group

Digital Depression HME DEVICE

A digital handheld press-down HME will be placed over stoma.

SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Mario A Landera, SLP.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: June 28, 2022
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)