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Completed

NCT Number: NCT05349487

SpeakFree Heat and Moisture Exchanger (HME)

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).

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Key information

Conditions

Laryngeal Cancer Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Laryngectomy Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SpeakFree HME Hands Free Valve

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

Other

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

Digital Depression HME

Device

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

Primary outcomes

  1. Satisfaction as measured by VAS

    Time frame: Up to 1 month

    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.

  2. Voice Quality: Patient Rating

    Time frame: Up to 1 month

    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.

Secondary outcomes

  1. Change in Maximum Phonation Time

    Time frame: Baseline, 1 month

    Maximum phonation time (MPT) is a clinical measurement of the longest time a person can phonate a vowel in seconds.

  2. Change in Syllables Per Breath

    Time frame: Baseline, 1 month

    Participants' number of syllables per breath while reading a standardized reading passage will be measured and reported.

  3. Pressure Needed to Phonate

    Time frame: Baseline

    Minimal and maximal pressures will be reported using a manometer while the participant counts from 1 to 15.

  4. Change in Voice Quality: Clinician Rating

    Time frame: Baseline, 1 month

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Acronym: SPEAKFREE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2022
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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