The Effects of a Mandibular Oral Repositioning Device on Sleep Quality, Heart Rate Variability, & SpO2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Total Sleep Duration
研究概览
简要总结
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.
详细描述
- Background and Rationale
Fatigue, stress, and burnout are increasingly prevalent among healthy, high-performance individuals. Two often-overlooked contributors are jaw misalignment (malocclusion) and over-breathing, both of which can impair respiratory efficiency, sleep quality, and physiological recovery.
The mandible is unique in the human body, suspended by muscles and ligaments rather than fixed joints. This provides a wide range of motion but makes it susceptible to misalignment during activity or sleep. Even mild malocclusion can compromise airway patency, neuromuscular coordination, and craniofacial balance. Consequences may include reduced respiratory efficiency, increased fatigue, impaired concentration, and elevated injury risk. Secondary issues from mouth-breathing and over-breathing - such as poor oxygen-carbon dioxide balance and disrupted sleep - further contribute to fatigue and suboptimal performance.
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 40-65 years
- •Male or female
- •Body mass index (BMI) between 25 and 35 kg/m²
- •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
排除标准
- •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
- •Current smoker or use of tobacco or vaping products
- •Presence of major medical or psychiatric conditions that may affect sleep or autonomic function (e.g., cardiovascular disease, uncontrolled hypertension, anxiety, or depression)
- •Pregnancy
研究组 & 干预措施
px3
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.
干预措施: Mandibular Oral Repositioning Appliance (Device)
Placebo Device
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.
干预措施: Mandibular Oral Repositioning Appliance (Device)
结局指标
主要结局
Total Sleep Duration
时间窗: 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)
Total sleep duration will be measured using a wrist-worn Garmin Forerunner 245 wearable device. Sleep duration will be calculated as the total time classified as sleep during each recorded night across baseline and intervention phases. Unit of Measure: Minutes (or hours)
Sleep Stage Proportions
时间窗: 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)
Sleep stage proportions (deep sleep, light sleep, REM sleep, and awake time) will be measured using a wrist-worn Garmin Forerunner 245 wearable device. Sleep stage data will be recorded continuously during baseline and intervention phases and summarized as the proportion of total sleep time spent in each sleep stage. Unit of Measure: Percentage (%) of total sleep time
Heart Rate Variability (HRV)
时间窗: 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 will be measured using a wrist-worn Garmin Forerunner 245 wearable device. HRV data will be collected continuously during baseline and intervention phases and extracted for analysis using device-derived metrics. Unit of Measure: Milliseconds (ms)
Blood Oxygen Saturation (SpO2)
时间窗: 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) will be measured using a wrist-worn Garmin Forerunner 245 wearable device. SpO₂ data will be recorded during sleep periods throughout baseline and intervention phases and extracted for analysis. Unit of Measure: Percentage (%)
次要结局
- Participant Comfort With the Device(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))
- Participant Adherence to Device Use(Immediately after each intervention phase (after Condition 1 and after Condition 2))
- Participant Experience Using the Device(Immediately after each intervention phase (after Condition 1 and after Condition 2))
- Participant-Perceived Effects of the Device(Immediately after each intervention phase (after Condition 1 and after Condition 2))
研究者
Christian Clermont
Adjunct Assistant Professor
University of Calgary