Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laryngeal Cancer | Malignant Laryngeal Neoplasm | CURATED_EXACT | 0.92 |
| Laryngectomy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Depression HME | Device | — | UNRESOLVED |
| Digital Occlusion | Other | — | UNRESOLVED |
| SpeakFree HME Hands Free Valve | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group
- description
- 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.
- interventionNames
- Device: SpeakFree HME Hands Free Valve
- Other: Digital Occlusion
- Device: Digital Depression HME
Primary outcomes (2)
- measure
- Satisfaction as measured by VAS
- timeFrame
- Up to 1 month
- description
- 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.
- measure
- Voice Quality: Patient Rating
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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