Gastroesophageal Reflux Disease
Conditions
Keywords
Gastroesophageal reflux, Sleep Apnea, Obstructive
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.
Interventions
DEVICEMandibular 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.
DEVICELower 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.
Sponsors
Tuiuti University of Paraná
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in nocturnal gastroesophageal reflux symptoms using the N-GSSIQ questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) | 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. |
| Change in daytime sleepiness using the Epworth Sleepiness Scale (ESS) | 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. |
| Change in salivary pH levels | 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. |
| Change in quality of life using the WHOQOL-BREF questionnaire | 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. |
Countries
Brazil
Contacts
Primary ContactFlávio M Gonçalves, PhD, DDS
Backup ContactRodolfo Jorge F Kubiak, MSc, DDS
Outcome results
None listed