Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea

Launched by TUIUTI UNIVERSITY OF PARANÁ · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a special mouthpiece, called a mandibular advancement device, can help reduce nighttime acid reflux in adults who have obstructive sleep apnea (a condition where breathing stops and starts during sleep). The device works by gently moving the lower jaw forward while you sleep. Researchers want to see if this device can not only lower acid reflux episodes at night but also improve sleep quality and overall daily well-being. They will compare this device to another similar mouthpiece that does not move the jaw forward to find out which works better.

Adults between 18 and 65 years old who have been diagnosed with obstructive sleep apnea and experience nighttime acid reflux may be eligible to join. Participants should not currently be using CPAP machines (a common treatment for sleep apnea) and need to have enough natural teeth to wear the mouthpieces comfortably. If you join, you will wear the assigned mouthpiece every night for six months, visit the clinic for regular check-ups and adjustments, and complete short questionnaires about your reflux symptoms, sleep, eating, and quality of life. The study will also measure saliva acidity and take X-rays before and after treatment. This research aims to offer a new option for people who find CPAP therapy hard to tolerate.

Gender

ALL

Eligibility criteria

• 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