NCT05349487Completed
SpeakFree Heat and Moisture Exchanger (HME)
Evaluation of a Disposable Hands-Free Heat and Moisture Exchanger (HME) Valve: The Blom-Singer SpeakFree HME Hands Free Valve
Source: ClinicalTrials.gov · Last updated 3 Feb 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 21 Apr 2022
- Start date
- Jun 2022
- Primary completion date
- Jan 2025
- Lead sponsor
- University of Miami
- Diseases
- Head and neck cancer
- NCT number
- NCT05349487
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From Jun 2022 to the primary completion date, Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who are currently receiving treatment for head and neck cancer.
Other illness
- Participants who have an underlying neurologic condition potentially impacting speech.
Other
- Participants who do not have a voice prosthesis.
- Participants who have dysarthria.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.