Custom mandibular oral repositioning device (px3™) to improve sleep quality, heart rate variability, and oxygen levels
The Effects of a Mandibular Oral Repositioning Device on Sleep Quality, Heart Rate Variability, & SpO2
This trial tests whether a custom mandibular oral repositioning appliance (px3™) helps healthy adults aged 40–65 with BMI 25–35 sleep better and improve heart-rate variability and nighttime oxygen levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT07359638 on ClinicalTrials.gov |
What this trial studies
Healthy adults aged 40–65 with BMI 25–35 will be fitted with either a px3™ mandibular advancement appliance or a custom neutral placebo device that does not advance the jaw. The px3™ gently advances and stabilizes the lower jaw during sleep to help maintain airway openness while the placebo holds the jaw in a neutral position. Participants will wear the assigned device during sleep while researchers collect subjective sleep quality data and objective measures including heart rate variability and nocturnal oxygen saturation using wearable and monitoring equipment. Outcomes will compare changes in sleep quality and physiological recovery between the px3™ and placebo groups.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults 40–65 years old with BMI 25–35, a full set of permanent teeth to the first molar, no diagnosed sleep disorder, not using CPAP, and available for in-person visits.
Not a fit: People with diagnosed moderate-to-severe sleep apnea or current CPAP use, significant TMJ dysfunction, active orthodontic work or dentures, smokers, major medical or psychiatric conditions, or pregnancy are unlikely to benefit or will be excluded.
Why it matters
Potential benefit: If successful, the device could provide a noninvasive way to improve breathing stability, sleep quality, and physiological recovery for middle-aged adults with mild jaw-related airway compromise.
How similar studies have performed: Mandibular advancement devices have demonstrated benefit for obstructive sleep apnea, but using a mild custom mandibular repositioning appliance to boost sleep and recovery in otherwise healthy middle-aged adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Calgary, Alberta
- Canadian Sport Institute Alberta — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Christian A Clermont, PhD — University of Calgary
- Study coordinator: Christian A Clermont, PhD
- Email: christian.clermont@ucalgary.ca
- Phone: 306-530-4787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.