SpeakFree Heat and Moisture Exchanger (HME) (SPEAKFREE)

University of Miami

Status: Completed

Conditions: Laryngeal Cancer; Laryngectomy

Treatments: Device: Digital Depression HME; Other: Digital Occlusion; Device: SpeakFree HME Hands Free Valve

Study type: Interventional

Funder types: Other

Identifiers

NCT05349487

20210501

Details and patient eligibility

About

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).

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group

Experimental group

Description:

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.

Treatment:

Device: SpeakFree HME Hands Free Valve

Other: Digital Occlusion

Device: Digital Depression HME