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Not yet recruitingPhase 3

Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea

Key facts

Who runs it
Tuiuti University of Paraná
Where
Brazil1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
Phase
Phase 3
People taking part
40 people, planned
Started
1 Aug 2025
Expected to end
1 Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Mandibular Advancement Device
  • Lower Oral Device Without Mandibular Advancement
Record updated
8 July 2025

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Current or recent use of proton pump inhibitors or other anti-reflux medications
  • Prior surgeries for apnea or reflux
  • Neurological or neuromuscular disorders
  • Known allergy or intolerance to dental acrylic materials
  • Severe OSA (Apnea-Hypopnea Index > 30)
  • Use of removable dental prostheses (partial or total)
  • Inability to attend follow-up visits or complete questionnaires

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Mandibular Advancement Device (MAD)Treatment being tested

    Participants in this group will receive a custom-made mandibular advancement device (MAD), designed to reposition the lower jaw forward during sleep. The appliance is used nightly for 180 days and aims to improve upper airway patency and reduce nighttime gastroesophageal reflux episodes. The device is made of heat-cured acrylic and adjusted based on individual mandibular protrusion measurements.

    Treatment: Mandibular Advancement Device

  • Lower Oral Device Without Mandibular Advancement (DIO)Existing treatment, for comparison

    Participants in this group will receive a lower jaw oral device that does not advance the mandible. The appliance is also indicated for patients with obstructive sleep apnea and provides dental disocclusion without altering jaw position. It will be used nightly for 180 days, serving as the control intervention. The device is fabricated similarly to the MAD but without mandibular repositioning.

    Treatment: Lower Oral Device Without Mandibular Advancement

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect of Oral Mandibular Advancement Devices on Nocturnal Gastroesophageal Reflux in Adults With Obstructive Sleep Apnea: A Randomized Controlled Trial
Fit questions
Built from NCT07049315, who can take part
Record updated
8 July 2025