Recruiting

px3™

Sponsor:

University of Calgary

Code:

NCT07359638

Conditions

Sleep

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

Interventions

Mandibular Oral Repositioning Appliance

Study Details

Brief summary:

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.

Conditions

Sleep

Study ID

NCT07359638

Start date

Feb 11, 2026

Status verified date

Apr, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

Interventions

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.

Primary outcome measure

  • Total Sleep Duration [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Christian A Clermont, PhD

306-530-4787christian.clermont@ucalgary.ca

Locations

Canadian Sport Institute Alberta

Recruiting

Calgary, Alberta, Canada, T3B 6B7

Contacts

Christian A Clermont, PhD

306-530-4787christian.clermont@ucalgary.ca

John Horton, MSc

jhorton@csialberta.ca

More Information

Sponsor

University of Calgary

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • mandibular oral appliance
  • sleep quality
  • heart rate variability
  • oxygen saturation
  • airway patency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-05-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.