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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:
Researchers will compare two types of oral appliances:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 180 days after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| José Stechman-Neto, PhD, DDS | Universidade Tuiuti do Paraná | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Tuiuti do Paraná - Centro de Diagnóstico das Alterações Temporomandibulares (CDATM) | Curitiba | Paraná | Brazil |
De-identified individual participant data (IPD) will be made available upon reasonable request to the principal investigator, after primary results are published.
Data will be available starting in July 2027 and will remain accessible for 5 years (until July 2032).
Qualified researchers with IRB/ethics committee approval
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| D019186 | Mandibular Advancement |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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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.
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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.
|
| 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. |
|
| 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. | 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. | 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. | Baseline and 180 days after intervention |
| D004066 | Digestive System Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D019647 |
| Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
| D009970 | Orthodontics |