SpeakFree Heat and Moisture Exchanger (HME)

Not Applicable

Completed

• Conditions: Laryngectomy; Laryngeal Cancer
• Interventions: Device: SpeakFree HME Hands Free Valve; Other: Digital Occlusion; Device: Digital Depression HME

• Registration Number: NCT05349487
• Lead Sponsor: University of Miami

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Study Start: 2022-06-28
• Status Verified: 2025-01
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-30
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group	Digital Occlusion	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.
SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group	SpeakFree HME Hands Free Valve	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.
SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group	Digital Depression HME	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.

Primary Outcome Measures

Name	Time	Method
Satisfaction as measured by VAS	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.
Voice Quality: Patient Rating	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 Outcome Measures

Name	Time	Method
Change in Syllables Per Breath	Baseline, 1 month	Participants' number of syllables per breath while reading a standardized reading passage will be measured and reported.
Change in Maximum Phonation Time	Baseline, 1 month	Maximum phonation time (MPT) is a clinical measurement of the longest time a person can phonate a vowel in seconds.
Change in Voice Quality: Clinician Rating	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.
Pressure Needed to Phonate	Baseline	Minimal and maximal pressures will be reported using a manometer while the participant counts from 1 to 15.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States