Custom mandibular oral repositioning device (px3™) to improve sleep quality, heart rate variability, and oxygen levels
Official title: The Effects of a Mandibular Oral Repositioning Device on Sleep Quality, Heart Rate Variability, & SpO2
Run by University of Calgary · NCT07359638 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 65 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | University of Calgary Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Calgary, Alberta) |
| Status | Recruiting |
| Started | February 11, 2026 |
| Main results expected | August 31, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07359638 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Multimodal Deep Learning to Predict Sleep Apnea Severity from SpO2 and Ballistocardiography
Researchers are testing a smart-mattress-based method that uses SpO2 and ballistocardiography data to predict sleep apnea severity in adults undergoing overnight sleep study.
-
Nightly wearable monitoring with at-home submental electrical stimulation for sleep apnea
This pilot test checks whether wearing a ring sensor at night and doing a 4-week at-home submental electrical stimulation is feasible for adults with obstructive sleep apnea and looks at changes in sleep metrics.
-
Functional capacity and muscle function in adults with obstructive sleep apnea
This study tests how obstructive sleep apnea affects respiratory and peripheral muscle strength, endurance, and upper‑extremity function compared with healthy adults.
-
Transcutaneous Electrical Stimulation for Obstructive Sleep Apnea
This study tests whether applying gentle electrical stimulation to the throat muscles at night can reduce sleep apnea severity in adults with obstructive sleep apnea.
-
Physical activity habits and sleep/ breathing in obstructive sleep apnea
This study tests whether daily physical activity habits affect sleep quality and breathing measurements in people with obstructive sleep apnea who are on CPAP therapy.
-
CES-EES score and a wearable ring for diagnosing obstructive sleep apnea
This study tests whether the CES-EES clinical score and the Belun Ring wearable can accurately diagnose obstructive sleep apnea without in-lab polysomnography in adults referred for suspected OSA.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.