Impact of a Mandibular Oral Repositioning Device on Sleep Quality, Heart Rate Variability, & SpO2

NCT07359638 | Recruiting

• 1 other identifier: REB25-1741
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Total Sleep Duration

  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)

  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

  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

  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)

  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)

  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)

  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 (%)

  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)

Secondary Outcomes (4)

• 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)

Study Arms (2)

px3

EXPERIMENTAL

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.

Device: Mandibular Oral Repositioning Appliance

Placebo Device

PLACEBO COMPARATOR

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.

Device: Mandibular Oral Repositioning Appliance

Interventions

Mandibular Oral Repositioning Appliance DEVICE

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 Device; px3

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Sport Institute Alberta: collaborator
• PX3: collaborator

Study Sites (1)

Canadian Sport Institute Alberta

Calgary, Alberta, T3B 6B7, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Christian A Clermont, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian A Clermont, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 22, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)