CLINICAL TRIAL

Digital Occlusion for Laryngectomy

Waitlist Available · 18+ · All Sexes · Miami, FL

SpeakFree Heat and Moisture Exchanger (HME)

See full description

About the trial for Laryngectomy

Eligible Conditions
Laryngectomy · Laryngeal Cancer · Laryngeal Neoplasms

Treatment Groups

This trial involves 2 different treatments. Digital Occlusion is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Digital Occlusion
OTHER
SpeakFree HME Hands Free Valve
DEVICE
Digital Depression HME
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have undergone a total laryngectomy at the University of Miami (UM) and use a voice prosthesis as your primary form of communication for at least 6 months prior to study enrollment. show original
Patients must demonstrate fluent tracheoesophageal speech (i.e. show original
Patients must have fully healed suture lines.
Current HME use for a minimum of 3 months.
You are willing to complete the survey and provide a signed Informed Consent Form. show original
You have a male and a female over the age of 18. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 1 month
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 1 month.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Digital Occlusion will improve 2 primary outcomes and 4 secondary outcomes in patients with Laryngectomy. Measurement will happen over the course of Baseline, 1 month.

Change in Maximum Phonation Time
BASELINE, 1 MONTH
Maximum phonation time (MPT) is a clinical measurement of the longest time a person can phonate a vowel in seconds.
Change in Syllables Per Breath
BASELINE, 1 MONTH
Participants' number of syllables per breath while reading a standardized reading passage will be measured and reported.
Change in Pressure Needed to Phonate
BASELINE, 1 MONTH
Minimal and maximal pressures will be reported using a manometer while the participant counts from 1 to 15.
Change in Voice Quality: Clinician Rating
BASELINE, 1 MONTH
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.
Satisfaction as measured by VAS
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
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.

Who is running the study

Principal Investigator
D. S. L.
Prof. Donna S. Lundy, Professor of Clinical
University of Miami

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for laryngectomy?

Sufficient information regarding treatment decisions and management is required before any specific treatment may be adopted. Further information will be necessary to guide treatment when a laryngectomy patient has no larynx and is being considered for the prosthetic replacement of a larynx.

Anonymous Patient Answer

Can laryngectomy be cured?

Laryngectomy is a drastic and challenging oncologic procedure associated with significant morbidity and mortality. Despite many advances in surgical techniques and perioperative care, the 5-year survival rate after laryngectomy remains low, and most patients remain cancer-free after surgery.

Anonymous Patient Answer

What is laryngectomy?

The primary purpose of a complete laryngectomy is to decrease the amount of speech impediment and improve quality of life in patients wishing to speak after surgical removal of the voicebox and supraglottic tissues (e.g. the glottis). The removal of the supraglottic tissues provides a unique opportunity for voice therapy and speech training that should be a component of the multispecialty treatment approach that is required to effectively treat patients with advanced laryngeal cancer. There is evidence to support the inclusion of specialized speech therapy in the treatment of laryngeal cancer but unfortunately the quantity and quality of research on speech therapy after larynx removal is limited.

Anonymous Patient Answer

What causes laryngectomy?

Many laryngectomies are the most successful treatments for vocal cord mobility disorders. However, the overall risk of surgery is only 1-3% of all laryngectomies as a result of a variety of issues, including but not limited to pre-existing medical conditions, personality, and smoking.

Anonymous Patient Answer

How many people get laryngectomy a year in the United States?

The American Laryngological Association estimates that 30,200 patients will undergo laryngectomy in the 5 years ending in 2030 in the United States, representing an annual average of 7,900 procedures.

Anonymous Patient Answer

What are the signs of laryngectomy?

Many patients experience a decline in their quality of life after laryngectomy, with the most prominent problems being social isolation, the loss of voice and the decrease or loss of physical abilities. Laryngectomy impacts patients' quality of life significantly.

Anonymous Patient Answer

What is the average age someone gets laryngectomy?

Mean age at the time of laryngectomy is 70.4 years. There is significant variation in the average age at onset of laryngeal cancer, with most patients developing early laryngeal cancer at an average age of 60.6 years over the last 7 years.

Anonymous Patient Answer

What does digital occlusion usually treat?

Although digital occlusion therapy has been used on a modest number of cases, clinicians still have questions regarding the role of digital occlusion therapy in relieving symptoms and improving quality of life of patients with laryngeal and pharyngeal cancer. Furthermore, the evidence regarding its potential therapeutic effect is inconsistent and limited.

Anonymous Patient Answer

Who should consider clinical trials for laryngectomy?

Patients with laryngeal cancer should be encouraged to take part in a clinical trial if they are thought to have a good prognosis, or if they want to be involved in future treatment decisions. Those with worse prognoses have little benefit from clinical trials, and they seem to be taking up the offer less. If considering clinical trials, be clear about your personal preferences and how they might be influenced by treatment options. Trial results do not always match patients' preferences and can result in negative outcomes, such as long-term quality of life deficits, or death. It is hard to determine if a patient will get a clinical trial offer; therefore, the individual patient-centered nature of the clinical trial is essential.

Anonymous Patient Answer

How does digital occlusion work?

The occlusion technique is dependent not only of the type of occluder used, but on the kind of occlusion used to achieve occlusion in a high degree of reproducibility between studies. In clinical practice, occlusion can be achieved using either digital occlusion devices or acrylic occlusion devices.

Anonymous Patient Answer

Has digital occlusion proven to be more effective than a placebo?

Digital occlusion is effective in inhibiting the transmission of HPV types in patients who are chronically infected with HPV 1 and 3. Results from a recent paper suggests that it is effective for all forms.

Anonymous Patient Answer

Does laryngectomy run in families?

Having an affected member in a family ndescends the patient psychologically. For family members, the patient's plight with the disease can ndepress the emotional situation. Most patients are concerned about their family members.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Laryngectomy by sharing your contact details with the study coordinator.