Status:
COMPLETED
SpeakFree Heat and Moisture Exchanger (HME)
Lead Sponsor:
University of Miami
Conditions:
Laryngeal Cancer
Laryngectomy
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05349487
Start Date
June 28 2022
End Date
January 30 2025
Last Update
February 3 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136