Mandibular Oral Repositioning Device for Sleep Quality
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a custom jaw positioning device can improve sleep quality and recovery in healthy adults. The device, called px3™, gently moves the lower jaw forward during sleep to help keep the airway open and improve breathing. Participants will use both the px3™ device and a placebo device that doesn't move the jaw, allowing researchers to compare their effects on sleep and recovery. Healthy adults with a body mass index (BMI) between 25 and 35, who have a full set of teeth and no diagnosed sleep disorders, might be a good fit for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance sleep quality for many.
What prior data suggests that this mandibular oral repositioning device is safe for improving sleep quality?
Research has shown that devices like the px3™ being tested are generally safe, though they can cause some side effects. The most common side effect involves minor changes in how teeth align; for instance, some individuals notice their upper and lower teeth no longer meet as before.
Other side effects may include jaw soreness or stiffness, increased saliva, or dry mouth. Mild allergic reactions, such as swelling or redness, occur less frequently.
While many tolerate the device well, awareness of these potential side effects is important. If discomfort arises, consulting the study team or a healthcare provider is advisable.12345Why are researchers excited about this trial?
The PX3™ Mandibular Oral Repositioning Appliance is unique because it aims to improve sleep quality by physically advancing and stabilizing the lower jaw to optimize airway openness. Unlike other treatments for sleep-related breathing issues, such as CPAP machines or surgery, this device uses a custom-fit design that gently aligns and locks the teeth, making it less invasive and potentially more comfortable. Researchers are excited because it leverages principles like Poiseuille's Law, which suggests that increasing airway volume can boost oxygen intake, potentially enhancing physiological efficiency and sleep quality.
What evidence suggests that this mandibular oral repositioning device is effective for improving sleep quality?
This trial will compare the PX3™ Mandibular Oral Repositioning Appliance with a placebo device. Studies have shown that devices like the PX3™ can improve sleep by keeping the airway open during sleep. Research indicates these devices can reduce snoring and enhance breathing, leading to better sleep and less daytime fatigue. Users of similar devices have reported feeling more rested and having increased energy. Although these devices are not as effective as CPAP (continuous positive airway pressure) machines for severe sleep apnea, they still offer significant benefits for those with mild to moderate issues. Overall, the PX3™ device may enhance sleep quality by gently moving the lower jaw forward to maintain an open airway.678910
Who Is on the Research Team?
Christian A Clermont, PhD
Principal Investigator
University of Calgary
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants wear the monitor without any oral device to establish baseline measurements
Intervention Phase 1
Participants are randomized to either the PX3™ or placebo device for the first intervention phase
Washout
Participants do not use any device to eliminate carryover effects between intervention phases
Intervention Phase 2
Participants switch to the alternate device for the second intervention phase
Follow-up
Participants are monitored for safety and effectiveness after completing both intervention phases
What Are the Treatments Tested in This Trial?
Interventions
- Mandibular Oral Repositioning Appliance
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The PX3™ Mandibular Oral Repositioning Appliance is designed to advance and stabilize the lower jaw, optimizing airway openness and physiological efficiency. The device functions similarly to the airway-opening maneuver used in cardiopulmonary resuscitation, slightly bringing the mandible forward to facilitate airflow. Each PX3™ appliance is custom-fitted to align and lock opposing teeth, stabilizing the jaw during sleep or high-stress activities. PX3™ designs are based on three physical principles: (i) Poiseuille's Law: Increasing airway volume increases oxygen intake. (ii) Gas Exchange Law: Optimized oxygen and carbon dioxide exchange enhances physiological function. (iii) Conservation of Energy Law: Greater oxygen availability improves mechanical efficiency.
The Placebo Device is a splint in centric occlusion with no mandibular advancement. The PX3™ Device advances the mandible 50-70% of maximum protrusion to improve alignment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Canadian Sport Institute Alberta
Collaborator
PX3
Collaborator
Citations
Mandibular advancement devices in obstructive sleep apnea
Although less effective than CPAP for improving AHI in moderate to severe OSA, several recent studies have found that oral appliances and CPAP were equally ...
Impact of a Mandibular Oral Repositioning Device on ...
This study will evaluate whether a custom mandibular oral repositioning appliance (px3™) improves sleep quality and recovery-related ...
Technological advances in mandibular advancement devices
Many patients report improvements such as less snoring, better sleep quality, and reduced daytime fatigue. However, when sleep apnea is moderate ...
Efficacy of Mandibular Advancement Devices in the ...
Outcomes: Treatment of OSA to improve quality of life and reduce the risk of cardiovascular complications, apnea-hypopnea index (AHI), oxygen saturation, and ...
Systematic review & Meta-analysis Efficacy and adherence ...
Efficacy and adherence of different mandibular advancement devices designs in treatment of obstructive sleep apnea: A systematic review and meta-analysis.
Side effects of mandibular advancement splints for the ... - PMC
The most uniformly reported mandibular advancement splint side effects were predominantly of dental nature and included a decrease in overjet and overbite.
7.
sleepwakeadvisor.com
sleepwakeadvisor.com/news/osa-mandibular-repositioning-appliance-adverse-events/As OSA Mandibular Repositioning Appliance Use ...
The most often-reported AEs involving allergic reactions were swelling (26.9%) and erythema (23.3%). Regarding AEs related to broken parts, only ...
The Occlusal Side Effects of Mandibular Advancement Device ...
The side effects reported were upper incisor retroclination, lower incisor proclination, decreased overjet and overbite, and change in the total occlusal ...
9.
goodtoothdentalcare.com
goodtoothdentalcare.com/the-hidden-dental-side-effects-of-sleep-apnea-oral-appliances-what-every-patient-should-know-before-treatment/The Hidden Dental Side Effects of Sleep Apnea Oral Appliances
Short-Term Effects (First 3 Weeks to 3 Months) · Long-Term Bite and Jaw Changes (6 Months to 5 Years) · TMJ and Muscular Effects.
Side Effects of Oral Appliance Therapy
The Potential Side Effects of Oral Appliance Therapy · Jaw soreness or stiffness. · Bite or tooth contact changes. · Dry mouth or excess saliva. · Muscle tension.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.