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SpeakFree Heat and Moisture Exchanger (HME)

SpeakFree Heat and Moisture Exchanger (HME)

Non Recruiting
18 years and older
All
Phase N/A

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Overview

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).

Eligibility

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 details
    Laryngeal Cancer
    Laryngectomy

NCT05349487

University of Miami

20 August 2025

FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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