Testing Mandibular against a placebo for sleep
Official title: Impact of a Mandibular Oral Repositioning Device on Sleep Quality, Heart Rate Variability, & SpO2
The Effects of a Mandibular Oral Repositioning Device on Sleep Quality, Heart Rate Variability, & SpO2
- 2 groups
- One site, in Calgary
- Recruiting
Interventions
- Medical device
Mandibular Oral Repositioning Appliance
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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Canadian Sport Institute Alberta
Calgary, Alberta
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Healthy adults aged 40-65 years
- +Body mass index (BMI) between 25 and 35 kg/m²
- +Male or female
- +Full set of permanent teeth to the first molar
- +No clinically diagnosed underbite (Class III malocclusion)
- +Generally healthy with no diagnosed sleep disorders
- +Not currently using continuous positive airway pressure (CPAP) therapy
- +Employed in predominantly desk-based or professional roles
Exclusion
- −Diagnosed underbite (Class III malocclusion)
- −Current orthodontic treatment, braces, dentures, or pending dental work
- −Use of CPAP therapy or diagnosis of severe sleep apnea
- −Significant temporomandibular joint (TMJ) pain or dysfunction
- −Presence of major medical or psychiatric conditions that may affect sleep or autonomic function (e.g., cardiovascular disease, uncontrolled hypertension, anxiety, or depression)
- −Current smoker or use of tobacco or vaping products
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is investigating how something functions in the body, rather than testing a treatment directly.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Mandibular Oral Repositioning Appliance.
Registry label: A: px3
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Mandibular Oral Repositioning Appliance.
Registry label: B: Placebo Device
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 40 years to 65 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 24 people.
The study is currently expected to finish around October 2026.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (no oral appliance) and throughout each intervention phase while wearing the PX3™ device and the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → device, through study completion (up to approximately 12 weeks).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Total Sleep Duration — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (no oral appliance) and throughout each intervention phase while wearing the PX3™ device and the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → device, through study completion (up to approximately 12 weeks).
Sleep Stage Proportions — measured over Baseline (no oral appliance) and throughout each intervention phase while wearing the PX3™ device and the placebo device, through study completion (up to approximately 12 weeks).
Heart Rate Variability (HRV) — measured over Baseline (no oral appliance) and throughout each intervention phase while wearing the PX3™ device and the placebo device, through study completion (up to approximately 12 weeks).
Blood Oxygen Saturation (SpO2) — measured over Baseline (no oral appliance) and throughout each intervention phase while wearing the PX3™ device and the placebo device, through study completion (up to approximately 12 weeks).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07359638 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Mandibular Oral Repositioning ApplianceDevice
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 40 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 40 years to 65 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (no oral appliance) and throughout each intervention phase while wearing the PX3™ device and the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → device, through study completion (up to approximately 12 weeks).
The study as a whole is currently expected to finish around 2026-10-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 24 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Calgary, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Fatigue, poor sleep quality, and reduced physiological recovery are common even among otherwise healthy adults. Subtle factors such as jaw position during sleep and breathing efficiency may contribute to these issues. The mandible (lower jaw) is suspended by muscles and ligaments rather than fixed joints, making it susceptible to small positional changes during sleep. Even mild misalignment of the lower jaw can reduce airway space, alter breathing mechanics, and disrupt sleep architecture, which may in turn affect autonomic regulation and recovery. This study will evaluate whether a custom mandibular oral repositioning appliance (px3™) improves sleep quality and recovery-related physiological measures compared with a placebo oral device. The px3™ device gently advances the lower jaw during sleep, which may help maintain airway openness and support more stable breathing. The placebo device is custom-fitted but holds the jaw in a neutral position without mandibular advancement, allowing for controlled comparison of device effects. Using a randomized crossover design, each participant will wear both the px3™ device and the placebo device during separate intervention phases, allowing participants to serve as their own control. The study will take place over approximately 12 weeks and includes baseline monitoring without any oral appliance, two intervention phases, a washout period between conditions, and a short follow-up period. Participants will undergo non-invasive digital dental scans to fabricate two custom oral devices. Sleep, heart rate variability (HRV), and blood oxygen saturation (SpO₂) will be continuously monitored using a wrist-worn wearable device throughout the study, except during bathing or charging. Participants will also complete brief questionnaires and sleep logs to report comfort, adherence, perceived effects, and factors that may influence sleep (e.g., illness, travel, or alcohol use). The primary outcomes of interest are changes in sleep stage distribution (including deep, light, and REM sleep), HRV, and SpO₂ when using the PX3™ device compared with the placebo device. Secondary outcomes include participant comfort, adherence, and user experience. The findings from this study will help determine whether mandibular oral repositioning may support sleep quality and physiological recovery in healthy adults.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.