Laryngeal Cancer, Laryngectomy
Conditions
Keywords
Stoma, Voice Prosthesis, Total Laryngectomy, Heat and Moisture Exchanger (HME)
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).
Interventions
DEVICESpeakFree HME Hands Free Valve
A voice prosthesis, SpeakFree HME Hands Free Valve, achieved with creation of a tracheoesophageal puncture will be placed over the stoma for 1 month.
OTHERDigital Occlusion
Using participant's own fingers, they will be putting their fingers over the stoma.
DEVICEDigital Depression HME
A digital handheld press-down HME will be placed over stoma.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Syllables Per Breath | Baseline, 1 month | Participants' number of syllables per breath while reading a standardized reading passage will be measured and reported. |
| Pressure Needed to Phonate | Baseline | Minimal and maximal pressures will be reported using a manometer while the participant counts from 1 to 15. |
| 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. |
Countries
United States
Outcome results
None listed