Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

All Conditions

Rare Diseases

Laryngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Laryngeal Cancer

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.

A voice prosthesis, SpeakFree HME Hands Free Valve, achieved with creation of a tracheoesophageal puncture will be placed over the stoma for 1 month.

SpeakFree HME Hands Free Valve

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

Digital Occlusion

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

Digital Depression HME

Jerri Halgowich

Mario A Landera, SLP.D.

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).

SpeakFree Heat and Moisture Exchanger (HME)

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

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.

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.

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

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

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
SpeakFree Heat and Moisture Exchanger (HME)	NCT05349487	Laryngeal Cance... Laryngectomy	SpeakFree HME H... Digital Occlusi... Digital Depress...	18 Years -	University of Miami
SpeakFree Heat and Moisture Exchanger (HME)	NCT05349487	Laryngeal Cance... Laryngectomy	SpeakFree HME H... Digital Occlusi... Digital Depress...	18 Years -	University of Miami

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