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

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.

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