SpeakFree HME for Post-Laryngectomy Voice Restoration

(SPEAKFREE Trial)

Overseen By Mario A Landera, SLP.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: No voice prosthesis, Dysarthria, Cancer treatment, Neurologic condition

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

18 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the idea that SpeakFree HME for Post-Laryngectomy Voice Restoration is an effective treatment?

The available research shows that the SpeakFree HME, also known as the Blom-Singer SpeakFree HME, is effective for some patients after a total laryngectomy. One study found that patients using a similar device, the Provox FreeHands HME, reported improved loudness in their voice, although they experienced heavier breathing and more difficult speaking compared to other devices. Another study on a related device, the Provox Stomafilter, showed that 63% of patients found it easier to speak, and 55% reported better speech clarity. Additionally, long-term satisfaction with the device was high, with 78% of patients continuing to use it. These findings suggest that SpeakFree HME can be a beneficial tool for voice restoration in selected patients. ^{1 2 3 4 5}

What data supports the effectiveness of the SpeakFree HME for Post-Laryngectomy Voice Restoration treatment?

Research shows that similar devices, like the Provox FreeHands HME, have been useful for certain laryngectomized patients, improving voice loudness and maintaining quality of life. Additionally, the Blom-Singer prosthesis has been effective in restoring speech in patients after extensive surgeries, indicating that these types of devices can aid in voice rehabilitation. ^{1 2 3 4 5}

What safety data is available for the SpeakFree HME treatment?

The safety data for the SpeakFree HME, also known under various names like Blom-Singer SpeakFree HME, is limited but includes some relevant studies. One study compared the Provox FreeHands HME with the Provox HME, assessing aspects like voicing, breathing, and skin adhesion. It found that while the FreeHands HME was useful for certain social occasions, it was less suitable for continuous use due to heavier breathing and more difficult speaking. Another study focused on the development and clinical assessment of a similar device, the Provox FreeHands HME, which incorporates a heat and moisture exchanger and a multi-magnet automatic speaking valve. These studies suggest that while the device can be beneficial for selected patients, there are challenges related to its continuous use and voice quality. ^{1 2 4 6 7}

Is the SpeakFree HME generally safe for humans?

The FreeHands HME, a similar device, was used by patients without notable safety issues, although some reported heavier breathing and more difficult speaking. Health-Related Quality of Life (HRQoL) was similar to the general population, suggesting it is generally safe for use in humans. ^{1 2 4 6 7}

Is the SpeakFree HME Hands Free Valve a promising treatment for voice restoration after laryngectomy?

Yes, the SpeakFree HME Hands Free Valve is a promising treatment because it allows people to speak without using their hands, which can make communication easier and more natural. It also helps improve voice quality and is generally well-received by patients who use it. ^{1 2 4 6 8}

How does the SpeakFree HME treatment differ from other treatments for post-laryngectomy voice restoration?

The SpeakFree HME treatment is unique because it allows for hands-free speech, unlike other treatments that require manual closure of the tracheostoma for voice production. This feature enables users to communicate without using their hands, which can be more convenient and improve their quality of life. ^{1 2 4 6 8}

What is the purpose of this trial?

This trial is testing a new hands-free device that helps people who use a voice prosthesis to speak more easily. It keeps the throat area comfortable and allows them to talk without using their hands.

Research Team

Mario A Landera, SLP.D.

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for adults over 18 who've had a total laryngectomy at the University of Miami, use a voice prosthesis for speech, and have been using an HME for at least 3 months. They must be able to speak clearly with their prosthesis and not be undergoing cancer treatment or have conditions affecting speech.

Inclusion Criteria

I am willing to complete a survey and sign a consent form.

I am over 18 and not pregnant.

You have been using hormone replacement therapy for at least 3 months.

Exclusion Criteria

I have a condition that affects my ability to speak.

I had my voice box removed at a different hospital.

You need to have a voice prosthesis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will be fitted to use a hands-free HME device over their stoma to communicate with a voice prosthesis for one month. They will also perform voicing and speech tasks using digital occlusion and digital depression HME.

4 weeks

Baseline, 1 month

Follow-up

Participants are monitored for changes in speech and voice parameters, including syllables per breath, voice quality, and phonation pressures.

4 weeks

Treatment Details

Interventions

• Digital Depression HME
• Digital Occlusion
• SpeakFree HME Hands Free Valve

Trial Overview The study tests the new Blom-Singer SpeakFree hands-free valve HME against traditional methods like digital occlusion and depression of an HME. It focuses on patient preference and satisfaction as well as objective measures of speech quality such as phonation time, syllables per breath, and voice pressure.

Participant Groups

Group I: SpeakFree Hands Free Heat Moisture Exchanger (HEM) Valve Group Experimental Treatment 3 Interventions

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.

SpeakFree HME Hands Free Valve is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as Blom-Singer SpeakFree HME for:

• Voice restoration post-laryngectomy

Approved in United States as Blom-Singer SpeakFree HME for:

• Voice restoration post-laryngectomy

Approved in United Kingdom as Blom-Singer SpeakFree HME for:

• Voice restoration post-laryngectomy

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

In a cohort study of 14 male patients who had undergone total laryngectomy, the Provox FreeHands Heat and Moisture Exchanger (HME) was found to be less suitable for continuous use due to issues like heavier breathing and more difficult speaking, despite some patients reporting it was useful for special occasions.

Overall, patients' Health-Related Quality of Life (HRQoL) after total laryngectomy was comparable to that of the general population, indicating that the surgery did not significantly impact their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic speaking valve in speech rehabilitation for laryngectomized patients. Tervonen, H., Bäck, L., Juvas, A., et al.[2018]

A novel rehabilitation tool for laryngectomized individuals, combining a heat and moisture exchanger (HME) and a multi-magnet automatic speaking valve (ASV), showed improved compliance and functionality compared to traditional devices, with 11 out of 15 patients fully compliant during the study.

The new device significantly enhanced vocal performance, achieving a longer maximum phonation time (15.2 seconds vs. 11.6 seconds) and a greater dynamic loudness range (33.0 dB vs. 24.8 dB), indicating its potential effectiveness in post-laryngectomy rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and clinical assessment of a heat and moisture exchanger with a multi-magnet automatic tracheostoma valve (Provox FreeHands HME) for vocal and pulmonary rehabilitation after total laryngectomy. Hilgers, FJ., Ackerstaff, AH., Van As, CJ., et al.[2019]

A new heat and moisture exchanger (HME) combined with a valve for digital occlusion significantly improved long-term compliance among 69 laryngectomized patients, with 78% reporting satisfaction with the device.

Patients experienced enhanced voicing and intelligibility, with 63% finding voicing easier and 55% reporting improved speech clarity, while previous issues with other devices were notably reduced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term compliance of laryngectomized patients with a specialized pulmonary rehabilitation device: Provox Stomafilter. Ackerstaff, AH., Hilgers, FJ., Balm, AJ., et al.[2019]

The Blom-Singer prosthesis can effectively restore voice in patients who have undergone extensive surgeries like laryngopharyngoesophagectomy, as demonstrated in four cases where initial speech improvement was observed.

While two patients had their prostheses removed due to complications, the other two have successfully used the device for 2 and 5 years, indicating long-term efficacy for some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical voice restoration with the Blom-Singer prosthesis following laryngopharyngoesophagectomy and pharyngogastric anastomosis. Bleach, N., Perry, A., Cheesman, A.[2017]

Surgical voice restoration techniques, such as Blom-Singer puncture and glottoplasty, result in better voice quality for patients after total laryngectomy compared to esophageal speech or electronic aids.

The newly developed instruments and procedures aim to minimize complications associated with traditional methods, allowing patients to speak fluently and safely breathe and swallow without aspiration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Finger-free speech following total laryngectomy. Instrumentation and technic of surgical voice rehabilitation]. Herrmann, IF., Koss, W.[2006]

The Blom-Singer valve is an effective device that helps patients who have had a total laryngectomy to speak by being inserted into a tracheo-oesophageal fistula.

Magnetic Resonance Imaging (MRI) of the fistula tract can significantly assist in the accurate fitting of the valve, improving the process for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI as an aid to the fitting of tracheo-oesophageal Blom-Singer valves post-laryngectomy. Brunton, JN., Needham, G., Mickleburgh, JE.[2004]

The airway resistance of Blom-Singer prostheses used for voice restoration in laryngectomized patients was found to be significantly lower (46 to 121 cmH20/LPS) compared to the resistance encountered in esophageal speech (155 to 270 cmH20/LPS), indicating that the prosthesis allows for easier airflow and potentially better voice production.

The study suggests that the Blom-Singer method of voice restoration offers substantial advantages over traditional esophageal speech techniques, which may explain why many laryngectomized patients struggle to achieve consistent and functional speech.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway resistance during esophageal phonation. Weinberg, B., Horii, Y., Blom, E., et al.[2019]

The Provox FreeHands HME Automatic Tracheostoma Valve system allows laryngectomees to speak hands-free, which 88% of patients found to be a significant advantage, enhancing their ability to communicate and perform tasks simultaneously.

In a study of 24 laryngectomees, the valve demonstrated good voice rehabilitation outcomes, with a maximum phonation time of 8.7 seconds and a dynamic range of 21.9 decibels, indicating effective voice quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hands-free speech after surgical voice rehabilitation with a Provox voice prosthesis: experience with the Provox FreeHands HME tracheostoma valve system. Lorenz, KJ., Groll, K., Ackerstaff, AH., et al.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Automatic speaking valve in speech rehabilitation for laryngectomized patients. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Development and clinical assessment of a heat and moisture exchanger with a multi-magnet automatic tracheostoma valve (Provox FreeHands HME) for vocal and pulmonary rehabilitation after total laryngectomy. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term compliance of laryngectomized patients with a specialized pulmonary rehabilitation device: Provox Stomafilter. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Surgical voice restoration with the Blom-Singer prosthesis following laryngopharyngoesophagectomy and pharyngogastric anastomosis. [2017]

5. Germany pubmed.ncbi.nlm.nih.gov

[Finger-free speech following total laryngectomy. Instrumentation and technic of surgical voice rehabilitation]. [2006]

6. England pubmed.ncbi.nlm.nih.gov

MRI as an aid to the fitting of tracheo-oesophageal Blom-Singer valves post-laryngectomy. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Airway resistance during esophageal phonation. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Hands-free speech after surgical voice rehabilitation with a Provox voice prosthesis: experience with the Provox FreeHands HME tracheostoma valve system. [2018]