MAD for Throat Cancer (Ronco-Onco Trial)

N/A

Recruiting

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Had received RTH in the Department of Radiation Oncology

Patients with oropharyngeal cancer diagnosis

Must not have

Under treatment with CPAP for sleep apnea

Edentation preventing retention of the oral appliance

Timeline

Screening 3 weeks

Treatment Varies

Follow Up done in morning from 6-8 sleep period, assessed in morning of each of 3 nights

Summary

This trial studied snoring and sleep apnea treatment with a MAD device in patients with OPC. Results show mixed success.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of using MAD may include discomfort in the jaw or face due to the device's position adjustment function. There might also be increased salivation or dry mouth and potential changes in bite alignment over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have undergone radiation therapy in the Radiation Oncology Department.

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I have been diagnosed with cancer in the back of my throat.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am using a CPAP machine for my sleep apnea.

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I cannot use dental devices due to missing teeth.

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I am currently taking pain or anxiety medication.

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I have been diagnosed with major depression.

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I am taking medication for insomnia.

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I have had a stroke in the past.

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My high blood pressure is not under control.

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I experience severe and frequent pain in my face or mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ done in morning from 6-8 sleep period, assessed in morning of each of 3 nights

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~done in morning from 6-8 sleep period, assessed in morning of each of 3 nights

This trial's timeline: 3 weeks for screening, Varies for treatment, and done in morning from 6-8 sleep period, assessed in morning of each of 3 nights for reporting.