Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea
NCT ID: NCT07049315
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
40 participants
INTERVENTIONAL
2025-08-01
2026-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
The experimental group will receive a mandibular advancement device (MAD) that repositions the lower jaw forward during sleep.
The comparator group will receive a lower jaw oral device without mandibular advancement.
Each participant will use the assigned device nightly for 6 months. There is no crossover between arms.
TREATMENT
TRIPLE
Study Groups
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Mandibular Advancement Device (MAD)
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.
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.
Lower Oral Device Without Mandibular Advancement (DIO)
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Tuiuti University of Paraná
OTHER
Responsible Party
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Flávio Magno Gonçalves
Professor
Principal Investigators
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José Stechman-Neto, PhD, DDS
Role: STUDY_DIRECTOR
Universidade Tuiuti do Paraná
Locations
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Universidade Tuiuti do Paraná - Centro de Diagnóstico das Alterações Temporomandibulares (CDATM)
Curitiba, Paraná, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NEC01
Identifier Type: -
Identifier Source: org_study_id
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