MAD for Throat Cancer

(Ronco-Onco Trial)

Recruiting at 1 trial location

Overseen By Matthieu Schmittbuhl, DDS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Opioids, Anxiolytics, Insomnia meds, others

Disqualifiers: Pregnancy, Edentation, Depression, Hypertension, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 12-15 weeks

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how effectively a mandibular advancement device (MAD) addresses snoring and sleep apnea in individuals with throat cancer. MAD is a mouthpiece that shifts the jaw forward to keep airways open during sleep. The study includes two groups: one uses the device in a slightly advanced position, and the other in a more forward position. Individuals with throat cancer who have completed radiation therapy and experience snoring or interrupted breathing during sleep might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding how MAD can improve sleep quality for throat cancer patients.

Will I have to stop taking my current medications?

If you are taking opioid or anxiety medications, or are under treatment for insomnia, you cannot participate in the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that this device is safe for patients with oropharyngeal cancer?

Research has shown that mandibular advancement devices (MAD) are generally safe for treating sleep apnea and snoring. Studies have found that these devices can significantly reduce symptoms like apnea, which are pauses in breathing, and improve oxygen levels at night in adults. This indicates they are usually well-tolerated over time.

The studies reported no major side effects. One study showed that using a custom-made MAD led to improvements after both 6 months and 2 years. Another study found that MADs effectively reduce snoring and are safe for adults to use.

While these devices are mainly used for sleep apnea, they are considered safe even for people with other health conditions. This is encouraging for anyone considering participation in a trial involving a MAD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the mandibular advancement appliance (MAD) for throat cancer because it offers a completely different approach compared to traditional treatments like surgery, radiation, or chemotherapy. The MAD works by physically adjusting the jaw's position to improve the airway, which could potentially enhance breathing and overall quality of life for patients. This novel approach is particularly appealing because it is non-invasive and focuses on mechanical adjustment rather than chemical or radiological intervention, offering a new avenue for managing symptoms of throat cancer.

What evidence suggests that the Mandibular Advancement Device (MAD) is effective for snoring and sleep apnea in patients with oropharyngeal cancer?

This trial will compare two different mandibular advancement devices (MADs) for throat cancer patients. Studies have shown that MADs effectively treat obstructive sleep apnea (OSA) by gently moving the lower jaw forward, which helps keep the airway open during sleep. Research indicates that MADs can reduce the number of breathing interruptions during sleep, improve sleep quality, and reduce snoring. This can be especially helpful for individuals with sleep-related breathing problems, such as those with oropharyngeal cancer. Overall, MADs are a recognized alternative to treatments like continuous positive airway pressure (CPAP) for managing sleep apnea symptoms. Participants in this trial will receive either an active MAD or a neutral MAD as a control. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with oropharyngeal cancer who have had radiation therapy, snore, or stop breathing while sleeping. More men than women can join. It's not for those without enough teeth to hold the device, on certain medications, with major depression, uncontrolled high blood pressure, a stroke history, using CPAP for sleep apnea, treating insomnia with drugs, or heavy substance users.

Inclusion Criteria

I am aware the study seeks both men and women, with fewer men participating.

I snore or stop breathing when I sleep.

I have undergone radiation therapy in the Radiation Oncology Department.

Exclusion Criteria

I am using a CPAP machine for my sleep apnea.

I cannot use dental devices due to missing teeth.

I am currently taking pain or anxiety medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with Mandibular Advanced Device (MAD) for snoring and sleep apnea, including 3 nights of home sleep data collection spaced 4-5 weeks apart

12-15 weeks

5 clinical visits, 3 home sleep data collection nights

Follow-up

Participants are monitored for safety and effectiveness after treatment with MAD

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MAD

Trial Overview The study tests how well patients tolerate and benefit from a Mandibular Advanced Device (MAD) designed to help with snoring and sleep apnea in people who've had cancer in their throat area. The 'Ronco-Onco' intervention will be evaluated alongside MAD.

How Is the Trial Designed?

Group I: MAD-active Active Control 1 Intervention

MAD = mandibular advancement appliance, in 60-70% forward position from maximum possible jaw advancement for a given participant

Group II: Neutral MAD- control Placebo Group 1 Intervention

Mandibular advancement appliance in neurtral-control position, 10-20% of advancement - a non functional position to open upper airway

MAD is already approved in United States, European Union for the following indications:

Approved in United States as Mandibular Advancement Device (MAD) for:

• Mild to moderate obstructive sleep apnea
• Snoring

Approved in European Union as Mandibular Advancement Device (MAD) for:

• Mild to moderate obstructive sleep apnea
• Snoring

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

In a study of 30 patients with obstructive sleep apnea-hypopnea syndrome (OSAHS), the use of a mandibular advancement device (MAD) significantly reduced the Apnea-Hypopnea Index (AHI) from 22.45 to 4.63 events per hour, indicating improved breathing during sleep.

The MAD also led to a notable decrease in snoring and an increase in oxygen saturation levels, along with a significant reduction in daytime sleepiness, demonstrating its efficacy as a treatment option for OSAHS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decrease of respiratory events in patients with obstructive sleep apnea-hypopnea syndrome using a mandibular advancement device assessed with split night polysomnography. García-Campos, E., Labra, A., Galicia-Polo, L., et al.[2020]

Mandibular advancing devices (MAD) significantly reduced snoring episodes from an average of 40.42 to 20.64 episodes per hour and improved the apnoea-hypopnoea index (AHI) from 12.78 to 6.35 events per hour in 19 patients over one month.

The treatment was well-tolerated with only mild, transient side effects reported, and most patients (16 out of 19) used the device every night, indicating high compliance with the MAD therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of mandibular advancing devices in the treatment of snoring and mild to moderate obstructive sleep apnoea syndrome]. Adriana, BL., Rusu, G., Mihăescu, T.[2010]

In a study of 30 patients with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS), 64.3% experienced successful treatment with a mandibular advancement device (MAD), with success linked to younger age, smaller cervical circumference, and lower apnea-hypopnea index (AHI) at baseline.

Patients with nasal abnormalities had significantly lower success rates with MAD treatment, while adherence to the device was not affected by upper airway or facial skeletal abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of upper airway abnormalities on the success and adherence to mandibular advancement device treatment in patients with Obstructive Sleep Apnea Syndrome. Prescinotto, R., Haddad, FL., Fukuchi, I., et al.[2022]

In a study of 100 patients with obstructive sleep apnea treated with a mandibular advancement device (MAD), 80 patients were found to have positional dependency, showing significant improvement in their apnea-hypopnea index (AHI) from 32.1 to 8.6 after treatment.

The success rate of MAD treatment was notably higher in position-dependent patients (57.5% achieving a significant reduction in AHI) compared to non-dependent patients (30.0%), indicating that understanding a patient's positional dependency can help predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of positional dependency on outcomes of treatment with a mandibular advancement device. Lee, CH., Jung, HJ., Lee, WH., et al.[2012]

In a study of 29 patients with moderate-to-severe Obstructive Sleep Apnea (OSA), the fully customizable Mandibular Advancement Device (IMYS) significantly reduced the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) after three months of use.

The IMYS device also improved oxygen saturation levels, indicating its potential effectiveness as a treatment option for patients with more severe forms of OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a modified mandibular advancement device for OSA treatment in a group of adult patients. Ciavarella, D., Campobasso, A., Cazzolla, AP., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8656912/

Mandibular advancement device use in obstructive sleep ... Mandibular advancement devices (MADs) are an alternative to continuous positive airway pressure for the management of obstructive sleep apnea (OSA).

2. jscimedcentral.com jscimedcentral.com/jounal-article-info/Journal-of-Sleep-Medicine-and-Disorders/Efficacy-of-Mandibular-Advancement-Device-Therapy-in-Patients-with-Sleep-Related-Breathing-Disorders-A-Retrospective-Study-11704

Efficacy of Mandibular Advancement Device Therapy in ... Prospective studies have shown the efficacy of MAD in reducing respiratory disturbance index, blood pressure, improved sleepiness, sleep quality ...

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2819305

Mandibular Advancement vs Combined Airway and ... The results of this randomized clinical trial indicate that mandibular advancement device and combined airway and positional therapy reduced snoring and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10670328/

A Multicenter Prospective Study on the Use of a Mandibular ... The main objective of this prospective study was the evaluation of 1 mm step titration of mandible advancement in the success of treating obstructive sleep ...

5. jtd.amegroups.org jtd.amegroups.org/article/view/17794/14522

An update on mandibular advancement devices for the ... This review will focus on the efficacy, effectiveness, design features, side-effects of and patient selection for MAD therapy. Comparison will also be made ...

6. glidewelldental.com glidewelldental.com/solutions/sleep-dentistry/mandibular-advancement-devices/silent-nite-sleep-appliance

Silent Nite – Oral Appliance for Sleep Apnea The Silent Nite Sleep Appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8906377/

Mandibular advancement devices in obstructive sleep apnea In addition, MAD improve nighttime oxygenation at all levels of disease severity in adult patients with benefits upon the social and adverse health consequences ...

8. mdpi.com mdpi.com/2306-5354/12/2/210

Different Oral Appliance Designs Demonstrate ... These findings suggest that certain Oral Appliance designs can enable highly efficacious treatment for patients with Obstructive Sleep Apnea. Given these ...