NCT07049315

Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea

Effect of Oral Mandibular Advancement Devices on Nocturnal Gastroesophageal Reflux in Adults With Obstructive Sleep Apnea: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tuiuti University of Paraná · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DEVICE	Mandibular Advancement Device	A custom-made intraoral appliance designed to reposition the mandible forward during sleep. The device increases the upper airway space by maintaining the lower jaw in a protruded position, aiming to reduce airway collapse and decrease nocturnal gastroesophageal reflux. It is fabricated from heat-cured acrylic based on individual dental impressions and bite registrations taken in a protruded mandibular position.
DEVICE	Lower Oral Device Without Mandibular Advancement	A lower jaw oral appliance made of heat-cured acrylic, fabricated from standard dental impressions and bite registration in habitual occlusion. This device does not reposition the mandible but provides posterior dental disocclusion. It is also used in patients with obstructive sleep apnea and serves as an active comparator to evaluate the specific impact of mandibular advancement on nocturnal gastroesophageal reflux.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-07-03
• Last updated: 2025-07-08

Locations

1 site across 1 country: Brazil