This clinical trial tests the use of the SpeakFree Hands Free Valve heat and moisture exchange (HME) system in improving speech following a total laryngectomy (removal of the larynx) in patients with head and neck cancer. The most common form of communication after a total laryngectomy is with a voice prosthesis that is achieved with creation of a tracheoesophageal puncture. In order to communicate with a voice prosthesis, the stoma (opening) needs to be covered using a finger, a HME which needs to be pressed, or a hands free HME which automatically covers the stoma through use of air pressure. The success rates of hands free HME valve use are not as high as using a finger to cover the stoma or regular HME use due to several factors such as surgical reconstruction, certain medical factors, and cost of the device. This new disposable hands free HME valve uses less air pressure to occlude the stoma and may improve speech and overall patient satisfaction.
Additional locations may be listed on ClinicalTrials.gov for NCT05349487.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine if use of the SpeakFree Hands Free HME to achieve voicing is preferable as determined by patient preference and satisfaction scales when compared to digital occlusion of the stoma and digital depression of an HME.
SECONDARY OBJECTIVE:
I. To determine if the SpeakFree Hands Free HME has improved objective measures of speech and voice parameters (1) maximum phonation time, (2) syllables per breath, and (3) minimum/maximum phonation pressures, and (4) a clinician rating of voice quality using a visual analog scale, when compared to digital occlusion of the stoma and digital depression of an HME.
OUTLINE:
Patients undergo a SpeakFree Hands Free Valve HME fitting and training session with a speech pathologist and perform objective measures of voicing and speech tasks over 60 minutes. Patients are followed up at 4-8-weeks to repeat the objective measures of voicing and speech tasks over 30 minutes.
After completion of study, patients are followed up at 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorMario Alberto Landera
