An interventional study of SpeakFree HME Hands Free Valve and Digital Occlusion in Laryngeal Cancer and Laryngectomy, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by University of Miami · Not applicable, Interventional, and Supportive care
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).
244 studies on the registry are indexed under Laryngeal Neoplasms; 63 are open to participants now.
This study's enrollment of 18 is below the median of 44 across 181 interventional studies indexed under Laryngeal Neoplasms.
Browse Laryngeal Neoplasms studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
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Exclusion Criteria:
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.
Device: SpeakFree HME Hands Free Valve · Other: Digital Occlusion · Device: Digital Depression HME
A voice prosthesis, SpeakFree HME Hands Free Valve, achieved with creation of a tracheoesophageal puncture will be placed over the stoma for 1 month.
Using participant's own fingers, they will be putting their fingers over the stoma.
A digital handheld press-down HME will be placed over stoma.
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.
Time frame: Up to 1 month
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.
Time frame: Up to 1 month
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.
Time frame: Baseline, 1 month
Change in Syllables Per Breath
Participants' number of syllables per breath while reading a standardized reading passage will be measured and reported.
Time frame: Baseline, 1 month
Pressure Needed to Phonate
Minimal and maximal pressures will be reported using a manometer while the participant counts from 1 to 15.
Time frame: Baseline
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.
Time frame: Baseline, 1 month
Plan to share: No
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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