Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea

Phase 3Not Yet RecruitingNCT07049315

Tuiuti University of Paraná40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Mandibular Advancement DeviceDEVICE

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.

Lower Oral Device Without Mandibular AdvancementDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in nocturnal gastroesophageal reflux symptoms using the N-GSSIQ questionnaire

Participants will complete the Nocturnal Gastroesophageal Reflux Symptom Severity and Impact Questionnaire (N-GSSIQ), a validated scale ranging from 0 to 36, where higher scores indicate worse nocturnal reflux symptoms. Assessments will be performed at baseline and after 180 days of nightly oral device use to compare symptom severity between groups.