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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the SpeakFree HME, designed to help individuals speak after voice box removal. It compares this hands-free device to other speech methods, focusing on user satisfaction and speech quality. Suitable participants have used a voice prosthesis for at least three months, rely on it as their primary communication method, and currently use a similar device for speaking. As an unphased trial, this study provides a unique opportunity to advance communication devices for those who have lost their voice box.

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 prior data suggests that the SpeakFree HME is safe for post-laryngectomy voice restoration?

Research shows that the SpeakFree HME Hands Free Valve helps people who have had their voice box removed speak more easily. Although specific safety data is not available, the SpeakFree HME is a new version of existing devices known as heat and moisture exchangers. These devices generally receive positive feedback because they filter and humidify the air, making breathing more comfortable after surgery.

The trial phase is marked as "Not Applicable," indicating an early-stage trial. This usually means the device is still being tested for safety and effectiveness. However, since it is based on existing technology (other HMEs), it is designed to be safe and comfortable for users. Those considering joining this trial might benefit from consulting a healthcare professional for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SpeakFree HME Hands Free Valve is unique because it allows individuals who have undergone a laryngectomy to communicate without using their hands. Traditional options often require manual occlusion to produce speech, which can be cumbersome and limit the use of hands for other tasks. This new valve integrates a hands-free mechanism with a heat and moisture exchanger, which not only facilitates easier communication but also helps maintain lung health by humidifying and warming the air entering the stoma. Researchers are excited about the SpeakFree valve because it promises to enhance the quality of life and independence for patients by making speech more natural and less reliant on manual assistance.

What evidence suggests that the SpeakFree HME is effective for post-laryngectomy voice restoration?

Research shows that the SpeakFree HME (Heat and Moisture Exchanger) hands-free valve can help individuals who have had their voice box removed speak more easily and comfortably. This device controls airflow through the speaking valve, facilitating speech. Early results suggest that the SpeakFree HME can handle different airflow levels, potentially helping users speak more naturally. It is designed to improve voice quality and extend the duration of speech without needing to pause for breath. Participants in this trial will use the SpeakFree HME and perform voicing and speech tasks using digital occlusion and digital depression HME, serving as their own control. The SpeakFree HME aims to increase user satisfaction compared to other methods, such as covering the neck opening with a hand. ^{1 3 4 6 7}

Who Is on the Research Team?

Mario A Landera, SLP.D.

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05349487?cond=%22Laryngeal%20Cancer%22&viewType=Table&rank=9

SpeakFree Heat and Moisture Exchanger (HME) 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11173334/

Role of the HME Filters during Physical Activity - PMC Methods: The objective of this clinical study was to evaluate the most suitable stomal filter for laryngectomy patients during physical activity. The filters ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-05481

SpeakFree Hands Free Heat Valve and Moisture ... This clinical trial tests the use of the SpeakFree Hands Free Valve heat and moisture exchange (HME) system in improving speech following a total laryngectomy.

4. withpower.com withpower.com/trial/phase-laryngectomy-4-2022-b5605

SpeakFree HME for Post-Laryngectomy Voice Restoration 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 ...

5. inhealth.com inhealth.com/media/documents/IHT_SpeakFree_Sales_Full_Sheet_FINAL_LR_2.pdf

New Blom-Singer® SpeakFree™ HME Hands Free Valve A SpeakFree™ HME all-in-one cartridge can be adjusted from as little as 45 liters of air to as much as 115 liters of air to attenuate the speaking valve. Data ...

6. severnhealthcare.com severnhealthcare.com/products/ent/inhealth/blom-singer-hands-free-hmes

Blom-Singer® SpeakFree HME Hands Free Valve Introducing the first HME cartridge with a fully integrated single-use adjustable hands free valve. We distribute voice restoration products in the UK.

7. fahl.com fahl.com/en/products/detail/d/BLOM-SINGER-SPEAKFREE

blom-singer ® speakfree™ hme hands free valve The Classic Flow® HME achieves high humidification, warming, filtering of the breathing air and adequate breathing resistance after laryngectomy. The lower ...