SpeakFree Heat and Moisture Exchanger (HME)

NCT ID: NCT05349487

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2025-01-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group

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.

Group Type: EXPERIMENTAL

SpeakFree HME Hands Free Valve

Intervention Type: 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.

Digital Occlusion

Intervention Type: OTHER

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

Digital Depression HME

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Digital Occlusion

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

Intervention Type: OTHER

Digital Depression HME

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Mario Alberto Landera, SLP.D

Associate Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mario A Landera, SLP.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20210501

Identifier Type: -

Identifier Source: org_study_id