Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea
ConditionGastroesophageal Reflux Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTuiuti University of Paraná
About this 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:
* 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Mandibular Advancement Device
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.
Lower Oral Device Without Mandibular Advancement
DeviceA 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Mandibular Advancement Device (MAD)Experimental treatment 1 intervention
Group B: Lower Oral Device Without Mandibular Advancement (DIO)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and 180 days after interventionSecondary outcomes
1
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.
Time frame
Baseline and 180 days after intervention2
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.
Time frame
Baseline and 180 days after intervention3
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.
Time frame
Baseline and 180 days after intervention4
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.
Time frame
Baseline and 180 days after interventionSponsors and contacts
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Source ClinicalTrials.gov
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