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Behavioural Intervention

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
Both female and male; with a ratio of 1/4 toward men
Reporting snoring and/or respiratory cessation complaints during sleep
Timeline
Screening 3 weeks
Treatment Varies
Follow Up done in morning from 6-8 sleep period, assessed in morning of each of 3 nights
Awards & highlights

Ronco-Onco Trial 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.Check my eligibility
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.See study design
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.

Ronco-Onco Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am aware the study seeks both men and women, with fewer men participating.
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I snore or stop breathing when I sleep.
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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.
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I am 18 years old or older.

Ronco-Onco Trial Timeline

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Index apnea-hypopnea
Snoring
Secondary outcome measures
Sleep quality

Ronco-Onco Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MAD-activeActive Control1 Intervention
MAD = mandibular advancement appliance, in 60-70% forward position from maximum possible jaw advancement for a given participant
Group II: Neutral MAD- controlPlacebo Group1 Intervention
Mandibular advancement appliance in neurtral-control position, 10-20% of advancement - a non functional position to open upper airway

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
365 Previous Clinical Trials
129,274 Total Patients Enrolled

Media Library

MAD (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05719779 — N/A
Throat Cancer Research Study Groups: MAD-active, Neutral MAD- control
Throat Cancer Clinical Trial 2023: MAD Highlights & Side Effects. Trial Name: NCT05719779 — N/A
MAD (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05719779 — N/A

Frequently Asked Questions

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

Is the age eligibility for this medical study restricted to those over 40 years old?

"This clinical experiment necessitates that participants are aged 18 to 65. There is a total of 44 separate trials for those younger than 18 and 777 dedicated studies for seniors above the age of 65."

Answered by AI

Are there any openings for persons wishing to participate in this clinical trial?

"Absolutely. Clinicaltrials.gov confirms that the trial is currently recruiting, which commenced on February 3rd 2023 and was last updated on May 9th 2023. 35 participants will be recruited from a single site."

Answered by AI

To what extent is this experiment involving human participants?

"Yes, the information on clinicaltrials.gov confirms that this research project is currently recruiting participants. This trial was initially advertised on February 3rd 2023 and recently updated on May 9th of the same year. Participants for this experiment will be accepted from one centre, with a total enrolment of 35 individuals."

Answered by AI

Is there an opportunity to join this experiment?

"For this medical experiment, 35 people aged 18-65 with oral cancers are being recruited. The ideal candidate should have a diagnosis of oropharyngeal cancer and be either male or female; preference is given to males in a 1:4 ratio. Additionally, they must have undergone radiation therapy at the Radiation Oncology Department and report having snoring issues and/or breathing cessation while sleeping."

Answered by AI
~19 spots leftby Jun 2025