MAD for Throat Cancer

(Ronco-Onco Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 2 Jurisdictions

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.

Trial 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 (Behavioural Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

CHUM Montréal, Canada

Who Is Running the Clinical Trial?

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

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] The mandibular advancement device (MAD) is a option to treat patients with Obstructive Sleep Apnea Syndrome (OSAS).

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] The Mandibular Advancement Device (MAD) is actually recommended for the treatment of Obstructive Sleep Apnea (OSA) with mild or moderate severity. The present study evaluated the effects of a fully customizable MAD-type device (It Makes You Sleep, IMYS), in patients with moderate-to-severe OSA.

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] Mandibular advancement device (MAD) may represent a feasible choice in the treatment of obstructive sleep apnea-hypopnea syndrome (OSAHS), in well selected patients.

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] Mandibular advancing devices (MAD) are a therapeutic option for snoring, mild obstructive sleep apnoea (OSA) and some patients with moderate or severe OSA non compliant to CPAP.

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

The effect of positional dependency on outcomes of treatment with a mandibular advancement device. [2012] To evaluate retrospectively the efficacy of the mandibular advancement device (MAD) in patients with obstructive sleep apnea in terms of positional dependency.