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SpeakFree HME for Post-Laryngectomy Voice Restoration (SPEAKFREE Trial)

N/A

Recruiting

Led By Donna S Lundy, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and non-pregnant females over the age of 18.

Patients must demonstrate fluent tracheoesophageal speech (i.e., maximum phonation time of at least 5 seconds during 3 consecutive trials).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 month

Awards & highlights

SPEAKFREE Trial Summary

This trial will compare the new Blom-Singer SpeakFree disposable hands free valve heat and moisture exchanger (HME) to other modalities of stomal occlusion for patients who communicate with a voice prosthesis, as determined by patient preference and satisfaction, and objective measures of speech and voice parameters.

Who is the study for?

This trial is for adults over 18 who've had a total laryngectomy at the University of Miami, use a voice prosthesis for speech, and have been using an HME for at least 3 months. They must be able to speak clearly with their prosthesis and not be undergoing cancer treatment or have conditions affecting speech.Check my eligibility

What is being tested?

The study tests the new Blom-Singer SpeakFree hands-free valve HME against traditional methods like digital occlusion and depression of an HME. It focuses on patient preference and satisfaction as well as objective measures of speech quality such as phonation time, syllables per breath, and voice pressure.See study design

What are the potential side effects?

While specific side effects are not detailed in this summary, typical concerns may include discomfort while using different valves or potential changes in voice quality which will be monitored through various speech assessments.

SPEAKFREE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and not pregnant.

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I can speak clearly through my voice prosthesis for at least 5 seconds.

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I had my voice box removed at UM and have used a voice prosthesis for over 6 months.

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My surgical wounds have completely healed.

SPEAKFREE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Satisfaction as measured by VAS

Voice Quality: Patient Rating

Secondary outcome measures

Change in Maximum Phonation Time

Change in Pressure Needed to Phonate

Change in Syllables Per Breath

+1 more

SPEAKFREE Trial Design

1Treatment groups

Experimental Treatment

Group I: SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve GroupExperimental Treatment3 Interventions

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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

University of MiamiLead Sponsor

901 Previous Clinical Trials

409,950 Total Patients Enrolled

Donna S Lundy, PhDPrincipal InvestigatorUniversity of Miami

1 Previous Clinical Trials

30 Total Patients Enrolled

Mario A Landera, SLP.D.Principal InvestigatorUniversity of Miami

Media Library

SpeakFree HME Hands Free Valve Clinical Trial Eligibility Overview. Trial Name: NCT05349487 — N/A

Laryngeal Cancer Research Study Groups: SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group

Laryngeal Cancer Clinical Trial 2023: SpeakFree HME Hands Free Valve Highlights & Side Effects. Trial Name: NCT05349487 — N/A

SpeakFree HME Hands Free Valve 2023 Treatment Timeline for Medical Study. Trial Name: NCT05349487 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open spots for participation in this experiment?

"Clinicaltrials.gov verifies that this medical study, which was published on June 28th 2022 and recently revised July 5th 2022, is actively looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SpeakFree Heat and Moisture Exchanger (HME)

Mario Alberto Landera, SLP.D 2022. "SpeakFree Heat and Moisture Exchanger (HME)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05349487.

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