Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea

NCT07049315 | Not Yet Recruiting Phase 3

• 1 other identifier: NEC01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux; Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and 180 days after intervention

Secondary Outcomes (4)

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

  Baseline and 180 days after intervention

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

  Baseline and 180 days after intervention

• Change in salivary pH levels

  Baseline and 180 days after intervention

• Change in quality of life using the WHOQOL-BREF questionnaire

  Baseline and 180 days after intervention

Study Arms (2)

Mandibular Advancement Device (MAD)

EXPERIMENTAL

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.

Device: Mandibular Advancement Device

Lower Oral Device Without Mandibular Advancement (DIO)

ACTIVE COMPARATOR

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.

Device: Lower Oral Device Without Mandibular Advancement

Interventions

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.

Mandibular Advancement Device (MAD)

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.

Lower Oral Device Without Mandibular Advancement (DIO)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tuiuti University of Paraná: lead

Study Sites (1)

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

Curitiba, Paraná, Brazil

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Sleep Apnea, Obstructive

Interventions

Occlusal Splints; Mandibular Advancement

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Orthodontics

Study Officials

• José Stechman-Neto, PhD, DDS

  Universidade Tuiuti do Paraná

  STUDY DIRECTOR

Central Study Contacts

Flávio M Gonçalves, PhD, DDS

CONTACT

+55(42)988167711; flaviomagno93@yahoo.com.br

Rodolfo Jorge F Kubiak, MSc, DDS

CONTACT

+55(42)999385573; dr.rodolfokubiak@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant, the primary investigator, and the assessor of outcomes will not know which device the participant receives. Only the provider who delivers the oral appliance will know.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to one of two parallel groups: 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.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available starting in July 2027 and will remain accessible for 5 years (until July 2032).
• Access Criteria: Qualified researchers with IRB/ethics committee approval

Locations

BR (1)