Back to resultsSpeakFree Heat and Moisture Exchanger (HME) (SPEAKFREE)
Primary Purpose
Laryngeal Cancer, Laryngectomy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SpeakFree HME Hands Free Valve
Digital Occlusion
Digital Depression HME
Sponsored by
About this trial
This is an interventional supportive care trial for Laryngeal Cancer focused on measuring Stoma, Voice Prosthesis, Total Laryngectomy, Heat and Moisture Exchanger (HME)
Eligibility Criteria
Inclusion Criteria:
- Participants who have undergone a total laryngectomy at the University of Miami (UM) who have and use a voice prosthesis as their primary form of communication for at least 6 months prior to study enrollment.
- Patients must have fully healed suture lines.
- Patients 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 3 months.
- 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:
- Patients that received a total laryngectomy at non-UM institutions.
- Patients who do not have a voice prosthesis.
- Patients who have dysarthria.
- Patients who are currently receiving treatment for head and neck cancer.
- Patients who have an underlying neurologic condition potentially impacting speech.
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Change in Syllables Per Breath
Participants' number of syllables per breath while reading a standardized reading passage will be measured and reported.
Change in Pressure Needed to Phonate
Minimal and maximal pressures will be reported using a manometer while the participant counts from 1 to 15.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05349487
Brief Title
SpeakFree Heat and Moisture Exchanger (HME)
Acronym
SPEAKFREE
Official Title
Evaluation of a Disposable Hands-Free Heat and Moisture Exchanger (HME) Valve: The Blom-Singer SpeakFree HME Hands Free Valve
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Cancer, Laryngectomy
Keywords
Stoma, Voice Prosthesis, Total Laryngectomy, Heat and Moisture Exchanger (HME)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
SpeakFree HME Hands Free Valve
Intervention Description
A voice prosthesis, SpeakFree HME Hands Free Valve, achieved with creation of a tracheoesophageal puncture will be placed over the stoma for 1 month.
Intervention Type
Other
Intervention Name(s)
Digital Occlusion
Intervention Description
Using participant's own fingers, they will be putting their fingers over the stoma.
Intervention Type
Device
Intervention Name(s)
Digital Depression HME
Intervention Description
A digital handheld press-down HME will be placed over stoma.
Primary Outcome Measure Information:
Title
Satisfaction as measured by VAS
Description
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.
Time Frame
Up to 1 month
Title
Voice Quality: Patient Rating
Description
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.
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Change in Maximum Phonation Time
Description
Maximum phonation time (MPT) is a clinical measurement of the longest time a person can phonate a vowel in seconds.
Time Frame
Baseline, 1 month
Title
Change in Syllables Per Breath
Description
Participants' number of syllables per breath while reading a standardized reading passage will be measured and reported.
Time Frame
Baseline, 1 month
Title
Change in Pressure Needed to Phonate
Description
Minimal and maximal pressures will be reported using a manometer while the participant counts from 1 to 15.
Time Frame
Baseline, 1 month
Title
Change in Voice Quality: Clinician Rating
Description
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.
Time Frame
Baseline, 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who have undergone a total laryngectomy at the University of Miami (UM) who have and use a voice prosthesis as their primary form of communication for at least 6 months prior to study enrollment.
Patients must have fully healed suture lines.
Patients 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 3 months.
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:
Patients that received a total laryngectomy at non-UM institutions.
Patients who do not have a voice prosthesis.
Patients who have dysarthria.
Patients who are currently receiving treatment for head and neck cancer.
Patients who have an underlying neurologic condition potentially impacting speech.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerri Halgowich
Phone
305-243-3818
Email
jhalgowich@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mario A Landera, SLP.D.
Phone
305-243-4315
Email
m.landera@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario A Landera, SLP.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerri Halgowich
Phone
305-243-3818
Email
jhalgowich@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Mario A Landera, SLP.D.
Phone
13052434315
Email
m.landera@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Mario A Landera, SLP.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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SpeakFree Heat and Moisture Exchanger (HME)
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