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NCT Number: NCT07049315

Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Apnea Deglutition Disorders Digestive System Diseases Dyssomnias Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universidade Tuiuti do Paraná - Centro de Diagnóstico das Alterações Temporomandibulares (CDATM)

Curitiba, Paraná, Brazil

Location contact

Flávio Magno Gonçalves, PhD

PRINCIPAL_INVESTIGATOR

Rodolfo Jorge F Kubiak, MSc

CONTACT

[email protected]

+55(42)999385573

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandibular advancement device

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

Device

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 outcomes

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

    Time frame: Baseline and 180 days after intervention

    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.

Secondary outcomes

  1. Change in sleep quality using the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline and 180 days after intervention

    The Pittsburgh Sleep Quality Index (PSQI), ranging from 0 to 21, where higher scores indicate worse sleep quality, will be administered at baseline and after 180 days of device use. The goal is to compare changes in global sleep quality scores between groups.

  2. Change in daytime sleepiness using the Epworth Sleepiness Scale (ESS)

    Time frame: Baseline and 180 days after intervention

    The Epworth Sleepiness Scale (ESS), ranging from 0 to 24, where higher scores indicate greater daytime sleepiness, will be used to measure excessive sleepiness at baseline and after 180 days of using the assigned oral device. Scores will be compared between groups.

  3. Change in salivary pH levels

    Time frame: Baseline and 180 days after intervention

    Salivary pH will be measured before and after the 180-day intervention period, using a standardized collection and digital pH meter. The goal is to assess whether the mandibular advancement device affects oral acidity associated with nocturnal reflux.

  4. Change in quality of life using the WHOQOL-BREF questionnaire

    Time frame: Baseline and 180 days after intervention

    Participants will complete the World Health Organization Quality of Life - BREF (WHOQOL-BREF), which provides domain scores ranging from 0 to 100, where higher scores indicate better quality of life. Assessments will occur at baseline and after 180 days to compare changes between groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Flávio M Gonçalves, PhD, DDS

CONTACT

[email protected]

+55(42)988167711

Rodolfo Jorge F Kubiak, MSc, DDS

CONTACT

[email protected]

+55(42)999385573

Sponsors and collaborators

Lead sponsor

Tuiuti University of Paraná

Other

Registry information

Official study title

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

Acronym: MAD-ROSA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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