SpeakFree Heat and Moisture Exchanger (HME)

Laryngeal Cancer Clinical Trial

— SPEAKFREE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05349487
• Other study ID #: 20210501
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: Jerri Halgowich
• Phone: 305-243-3818
• Email: jhalgowich[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Laryngeal Cancer
• Laryngeal Neoplasms
• Laryngectomy

Intervention

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

Other:
• Digital Occlusion
Using participant's own fingers, they will be putting their fingers over the stoma.

Device:
• Digital Depression HME
A digital handheld press-down HME will be placed over stoma.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction as measured by VAS	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.	Up to 1 month
Primary	Voice Quality: Patient Rating	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.	Up to 1 month
Secondary	Change in Maximum Phonation Time	Maximum phonation time (MPT) is a clinical measurement of the longest time a person can phonate a vowel in seconds.	Baseline, 1 month
Secondary	Change in Syllables Per Breath	Participants' number of syllables per breath while reading a standardized reading passage will be measured and reported.	Baseline, 1 month
Secondary	Pressure Needed to Phonate	Minimal and maximal pressures will be reported using a manometer while the participant counts from 1 to 15.	Baseline
Secondary	Change in Voice Quality: Clinician Rating	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.	Baseline, 1 month