MAD for Throat Cancer

(Ronco-Onco Trial)

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

Trial Summary

What is the purpose of this trial?

Evaluation of the Tolerance and Benefits of Mandibular Advanced Device (MAD) for Snoring and Sleep Apnea in Patients with Oropharyngeal Cancer (OPC): Mixed Design Study.

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.

Is the Mandibular Advancement Device (MAD) safe for humans?

The Mandibular Advancement Device (MAD) has been used safely in humans for conditions like snoring and obstructive sleep apnea (OSA). While these studies focus on sleep-related issues, they suggest that MAD is generally safe for human use. ^{1 2 3 4 5}

How does the MAD treatment for throat cancer differ from other treatments?

The MAD treatment is unique because it involves using a device to reposition the jaw, which is typically used for sleep apnea and snoring, rather than traditional cancer treatments like surgery or chemotherapy. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

1. Brazil 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. [2022]

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

The efficacy of a modified mandibular advancement device for OSA treatment in a group of adult patients. [2023]

3. Germany 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. [2020]

4. Romania pubmed.ncbi.nlm.nih.gov

[The use of mandibular advancing devices in the treatment of snoring and mild to moderate obstructive sleep apnoea syndrome]. [2010]

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

The effect of positional dependency on outcomes of treatment with a mandibular advancement device. [2012]