Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea

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.

NCT Number	NCT07049315
Lead Sponsor	Tuiuti University of Paraná
Conditions	Gastroesophageal Reflux Disease
Enrollment	40 participants
Start Date	2025-08-01
Primary Completion	2026-08-01 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-07-08