Laryngeal CancerSPEAKFREENCT05349487
SpeakFree Heat and Moisture Exchanger (HME)
A study testing SpeakFree HME Hands Free Valve, Digital Occlusion and Digital Depression HME in people with Laryngeal Cancer and Laryngectomy, run by University of Miami at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Cancer, Laryngectomy
- What is being tested?
- SpeakFree HME Hands Free Valve, Digital Occlusion and Digital Depression HME
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2022to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Disposable Hands-Free Heat and Moisture Exchanger (HME) Valve: The Blom-Singer SpeakFree HME Hands Free Valve
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
- Laryngeal Cancer, Laryngectomy
- Being tested
- SpeakFree HME Hands Free Valve, Digital Occlusion, Digital Depression HME
- Keywords
- Stoma, Voice Prosthesis, Total Laryngectomy, Heat and Moisture Exchanger (HME)
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpeakFree HME Hands Free ValveDevice
A voice prosthesis, SpeakFree HME Hands Free Valve, achieved with creation of a tracheoesophageal puncture will be placed over the stoma for 1 month.
Digital OcclusionOther
Using participant's own fingers, they will be putting their fingers over the stoma.
Digital Depression HMEDevice
A digital handheld press-down HME will be placed over stoma.
| Study group | Role | What they receive |
|---|---|---|
| SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group | Experimental | 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. Receives: Device: SpeakFree HME Hands Free Valve; Other: Digital Occlusion; Device: Digital Depression HME |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 1 month
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start28 Jun 2022
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Alberto Landera, SLP.D, University of Miami
- Investigators
- Mario A Landera, SLP.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349487
- Sponsor's protocol ID
- 20210501
- Acronym
- SPEAKFREE
- Status last verified
- Jan 2025
- First submitted
- 21 Apr 2022
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Disposable Hands-Free Heat and Moisture Exchanger (HME) Valve: The Blom-Singer SpeakFree HME Hands Free Valve
- ClinicalTrials.gov ID
- NCT05349487
- Acronym / sponsor ID
- SPEAKFREE / 20210501
- Conditions
- Laryngeal Cancer, Laryngectomy
- Keywords
- Stoma, Voice Prosthesis, Total Laryngectomy, Heat and Moisture Exchanger (HME)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group | Experimental | Device: SpeakFree HME Hands Free Valve, Other: Digital Occlusion, Device: Digital Depression HMEParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpeakFree HME Hands Free ValveA voice prosthesis, SpeakFree HME Hands Free Valve, achieved with creation of a tracheoesophageal puncture will be placed over the stoma for 1 month. | Device | SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group |
| Digital OcclusionUsing participant's own fingers, they will be putting their fingers over the stoma. | Other | SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group |
| Digital Depression HMEA digital handheld press-down HME will be placed over stoma. | Device | SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group |
Primary outcome
Satisfaction as measured by VAS
Time frame: 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
Time frame: 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.
4 secondary outcomes
Change in Maximum Phonation Time
Time frame: Baseline, 1 month
Change in Syllables Per Breath
Time frame: Baseline, 1 month
Pressure Needed to Phonate
Time frame: Baseline
Change in Voice Quality: Clinician Rating
Time frame: Baseline, 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario A Landera, SLP.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpeakFree HME Hands Free Valve, Digital Occlusion and Digital Depression HME in people with Laryngeal Cancer and Laryngectomy, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction as measured by VAS (time frame: Up to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.