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Not yet recruiting NCT07049315

Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea

Phase III Interventional Gastroesophageal Reflux Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mandibular Advancement Device, Lower Oral Device Without Mandibular Advancement.
Who it may be relevant to
Registry conditions: Gastroesophageal Reflux Disease. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • 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.

Primary outcome measures

  • Change in nocturnal gastroesophageal reflux symptoms using the N-GSSIQ questionnaire [Time frame: Baseline and 180 days after intervention]
Secondary outcome measures (4)
  • Change in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline and 180 days after intervention]
  • Change in daytime sleepiness using the Epworth Sleepiness Scale (ESS) [Time frame: Baseline and 180 days after intervention]
  • Change in salivary pH levels [Time frame: Baseline and 180 days after intervention]
  • Change in quality of life using the WHOQOL-BREF questionnaire [Time frame: Baseline and 180 days after intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Universidade Tuiuti do Paraná - Centro de Diagnóstico das Alterações Temporomandibulares ( — Curitiba

Identifiers

NCT: NCT07049315 · NEC01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗