SpeakFree Heat and Moisture Exchanger (HME)

Study Overview
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Brief Summary
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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).

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

Conditions
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Laryngeal Cancer, Laryngectomy

Intervention / Treatment
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* Device: SpeakFree HME Hands Free Valve
* Other: Digital Occlusion
* Device: Digital Depression HME


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who have undergone a total laryngectomy at the University of Miami (UM) who have and use a voice prosthesis as their primary form of communication for at least 6 months prior to study enrollment. Patients must have fully healed suture lines. Patients 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 3 months. 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: Patients that received a total laryngectomy at non-UM institutions. Patients who do not have a voice prosthesis. Patients who have dysarthria. Patients who are currently receiving treatment for head and neck cancer. Patients who have an underlying neurologic condition potentially impacting speech.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group<br>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<br>* A voice prosthesis, SpeakFree HME Hands Free Valve, achieved with creation of a tracheoesophageal puncture will be placed over the stoma for 1 month.<br>Other: Digital Occlusion<br>* Using participant's own fingers, they will be putting their fingers over the stoma.<br>Device: Digital Depression HME<br>* A digital handheld press-down HME will be placed over stoma.<br>|

What is the study measuring?
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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 Pressure Needed to Phonate | Minimal and maximal pressures will be reported using a manometer while the participant counts from 1 to 15. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stoma, Voice Prosthesis, Total Laryngectomy, Heat and Moisture Exchanger (HME)