Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea (NCT07049315) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea
Brazil40 participantsStarted 2025-08-01
Plain-language summary
The purpose of this randomized clinical trial is to learn if a mandibular advancement device (a type of oral appliance) can help reduce nighttime acid reflux in adults with obstructive sleep apnea. The study also aims to understand whether this device can improve sleep quality and quality of life.
The main questions the study aims to answer are:
* Does using a mandibular advancement device reduce the number and intensity of nighttime reflux episodes?
* Does the device improve sleep and daily well-being in people with sleep apnea and reflux?
Researchers will compare two types of oral appliances:
* A mandibular advancement device, which moves the lower jaw forward during sleep
* A lower jaw oral device without advancement, which also aims to help people with sleep apnea but does not reposition the jaw
Participants will:
Wear the assigned oral device every night for 6 months Visit the clinic for check-ups and adjustments Complete short questionnaires about reflux symptoms, sleep quality, swallowing, diet, and quality of life Have saliva pH measured and X-rays taken before and after using the device This study hopes to find out whether oral devices can be a good option for people who do not tolerate CPAP therapy.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 to 65 years
* Clinical diagnosis of obstructive sleep apnea (OSA) confirmed by polysomnography type I
* Presence of nocturnal gastroesophageal reflux symptoms
* Not currently using CPAP therapy
* Dentate individuals able to wear oral devices
* Able and willing to comply with the study protocol
* Provided written informed consent
Exclusion Criteria:
* Severe OSA (Apnea-Hypopnea Index \> 30)
* Current or recent use of proton pump inhibitors or other anti-reflux medications
* Neurological or neuromuscular disorders
* Use of removable dental prostheses (partial or total)
* Prior surgeries for apnea or reflux
* Known allergy or intolerance to dental acrylic materials
* Inability to attend follow-up visits or complete questionnaires
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in nocturnal gastroesophageal reflux symptoms using the N-GSSIQ questionnaire
Timeframe: Baseline and 180 days after intervention