Using a device to help with snoring and sleep apnea in patients with oropharyngeal cancer.
Evaluation of the Tolerance and Benefits of Mandibular Advanced Device for Snoring and Sleep Apnea in Patients With Oropharyngeal Cancer: Mixed Design Study.
This study is testing a special mouth device to see if it can help people with oropharyngeal cancer who snore and have sleep apnea sleep better after their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Drugs / interventions | Radiation, chemotherapy |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05719779 on ClinicalTrials.gov |
What this trial studies
This study evaluates the tolerance and benefits of a Mandibular Advanced Device (MAD) for patients suffering from snoring and sleep apnea due to oropharyngeal cancer. Conducted at the Centre Hospitalier Université de Montréal, it focuses on patients who have undergone radiotherapy and report sleep-related issues. The study aims to assess how effectively the MAD can improve sleep quality and reduce respiratory interruptions during sleep. Participants will be monitored for their experiences with the device and any associated health improvements.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of oropharyngeal cancer who have received radiotherapy and report snoring or respiratory cessation during sleep.
Not a fit: Patients who are pregnant, edentulous, or have a history of major depression or uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve sleep quality and overall health for patients with oropharyngeal cancer experiencing sleep apnea and snoring.
How similar studies have performed: Other studies have shown promise in using oral appliances for sleep apnea, suggesting potential success for this approach in a cancer population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * oropharyngeal cancer diagnosis * 18 years of age and over * female or male; ratio of 1/4 toward men * had received RTH in the Department of Radiation Oncology, * reporting snoring and/or respiratory cessation complaints during sleep, Exclusion Criteria: * pregnant or breastfeeding woman; * edentation preventing retention of the oral appliance; * taking opioid or anxiolitic type medications; * history of major depression, * uncontrolled hypertension, * history of stroke; * under treatment with CPAP for sleep apnea; * regular and intense orofacial pain; * under pharmacological treatment for insomnia; * excessive alcohol or drug use (e.g., cannabis, opioid).
Where this trial is running
Montreal, Quebec
- Chum — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Gilles Lavigne, DMD, PhD
- Email: gilles.lavigne@umontreal.ca
- Phone: 514-343-2310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.