Gastroesophageal Reflux DiseasePhase 3MAD-ROSANCT07049315
Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea
A Phase 3 study testing Mandibular Advancement Device and Lower Oral Device Without Mandibular Advancement in people with Gastroesophageal Reflux Disease, run by Tuiuti University of Paraná at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Mandibular Advancement Device and Lower Oral Device Without Mandibular Advancement
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2025to 1 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Universidade Tuiuti do Paraná - Centro de Diagnóstico das Alterações Temporomandibulares (CDATM)
Curitiba, Paraná
Rodolfo Jorge F Kubiak, MSc, +55(42)999385573, dr.rodolfokubiak@hotmail.com
Flávio Magno Gonçalves, PhD
About this study
Official title: Effect of Oral Mandibular Advancement Devices on Nocturnal Gastroesophageal Reflux in Adults With Obstructive Sleep Apnea: A Randomized Controlled Trial
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:
Read more
- 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
- Being tested
- Mandibular Advancement Device, Lower Oral Device Without Mandibular Advancement
- Keywords
- Gastroesophageal reflux, Sleep Apnea, Obstructive
- Medical subject headings
- Gastroesophageal Reflux, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Advancement DeviceDevice
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 AdvancementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Lower Oral Device Without Mandibular Advancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 180 days after intervention
Secondary outcomes (4)
Change in sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline and 180 days after intervention
Change in daytime sleepiness using the Epworth Sleepiness Scale (ESS)
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.
Measured: Baseline and 180 days after intervention
Change in salivary pH levels
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.
Measured: Baseline and 180 days after intervention
Change in quality of life using the WHOQOL-BREF questionnaire
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.
Measured: Baseline and 180 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tuiuti University of Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flávio Magno Gonçalves, Tuiuti University of Paraná
- Investigators
- José Stechman-Neto, PhD, DDS, Study director, Universidade Tuiuti do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049315
- Sponsor's protocol ID
- NEC01
- Acronym
- MAD-ROSA
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available upon reasonable request to the principal investigator, after primary results are published.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Mandibular Advancement Devices on Nocturnal Gastroesophageal Reflux in Adults With Obstructive Sleep Apnea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07049315
- Acronym / sponsor ID
- MAD-ROSA / NEC01
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal reflux, Sleep Apnea, Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tuiuti University of ParanáUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mandibular Advancement Device (MAD) | Experimental | Device: Mandibular Advancement DeviceParticipants 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. |
| Lower Oral Device Without Mandibular Advancement (DIO) | Active comparator | Device: Lower Oral Device Without Mandibular AdvancementParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular Advancement DeviceA 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. | Device | Mandibular Advancement Device (MAD) |
| Lower Oral Device Without Mandibular AdvancementA 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. | Device | Lower Oral Device Without Mandibular Advancement (DIO) |
Primary outcome
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.
4 secondary outcomes
Change in sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 180 days after intervention
Change in daytime sleepiness using the Epworth Sleepiness Scale (ESS)
Time frame: Baseline and 180 days after intervention
Change in salivary pH levels
Time frame: Baseline and 180 days after intervention
Change in quality of life using the WHOQOL-BREF questionnaire
Time frame: Baseline and 180 days after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available upon reasonable request to the principal investigator, after primary results are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
José Stechman-Neto, PhD, DDS study director
Universidade Tuiuti do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mandibular Advancement Device and Lower Oral Device Without Mandibular Advancement in people with Gastroesophageal Reflux Disease, run by Tuiuti University of Paraná at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flávio M Gonçalves, PhD, DDS (+55(42)988167711, flaviomagno93@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nocturnal gastroesophageal reflux symptoms using the N-GSSIQ questionnaire (time frame: Baseline and 180 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025; AzTrials last refreshed its copy on 3 Nov 2026.