Effect of Oral Mandibular Advancement Devices on Nocturnal Gastroesophageal Reflux in Adults With Obstructive Sleep Apnea: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in nocturnal gastroesophageal reflux symptoms using the N-GSSIQ questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mandibular Advancement Device (MAD)
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.
干预措施: Mandibular Advancement Device (Device)
Lower Oral Device Without Mandibular Advancement (DIO)
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.
干预措施: Lower Oral Device Without Mandibular Advancement (Device)
结局指标
主要结局
Change in nocturnal gastroesophageal reflux symptoms using the N-GSSIQ questionnaire
时间窗: 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.
Change in nocturnal gastroesophageal reflux symptoms using the N-GSSIQ questionnaire
时间窗: 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.
次要结局
- 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)
- 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)
研究者
Flávio Magno Gonçalves
Professor
Tuiuti University of Paraná