Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea (MAD-ROSA)

Tuiuti University of Paraná

Status and phase: Not yet enrolling; Phase 3

Conditions: Gastroesophageal Reflux Disease

Treatments: Device: Lower Oral Device Without Mandibular Advancement; Device: Mandibular Advancement Device

Study type: Interventional

Funder types: Other

Identifiers

NCT07049315

NEC01

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Mandibular Advancement Device (MAD)

Experimental group

Description:

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:

Device: Mandibular Advancement Device

Lower Oral Device Without Mandibular Advancement (DIO)

Active Comparator group

Description:

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:

Device: Lower Oral Device Without Mandibular Advancement