SpeakFree Heat and Moisture Exchanger (HME) (SPEAKFREE)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Laryngeal Cancer; Laryngectomy
• Intervention / Treatment: Device: SpeakFree HME Hands Free Valve; Other: Digital Occlusion; Device: Digital Depression HME

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jerri Halgowich; Phone Number: 305-243-3818; Email: jhalgowich@med.miami.edu
• Study Contact Backup: Name: Mario A Landera, SLP.D.; Phone Number: 305-243-4315; Email: m.landera@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Jerri Halgowich; Phone Number: 305-243-3818; Email: jhalgowich@med.miami.edu
      • Contact: Mario A Landera, SLP.D.; Phone Number: 13052434315; Email: m.landera@med.miami.edu
      • Principal Investigator: Mario A Landera, SLP.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum Phonation Time	Maximum phonation time (MPT) is a clinical measurement of the longest time a person can phonate a vowel in seconds.	Baseline, 1 month
Change in Syllables Per Breath	Participants' number of syllables per breath while reading a standardized reading passage will be measured and reported.	Baseline, 1 month
Change in Voice Quality: Clinician Rating	The clinician will rate participant's voice quality using VAS. VAS has a total score ranging from 1 to 10 with the higher score indicating that the clinician feels that participant's voice quality is better with the device.	Baseline, 1 month
Pressure Needed to Phonate	Minimal and maximal pressures will be reported using a manometer while the participant counts from 1 to 15.	Baseline

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Mario A Landera, SLP.D., University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Stoma; Total Laryngectomy; Voice Prosthesis; Heat and Moisture Exchanger (HME)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Laryngeal Diseases; Laryngeal Neoplasms
• Other Study ID Numbers: 20210501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No