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

RecruitingNAAges 40 Years - 65 YearsAllUniversity of Calgary
NCT07359638 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 devi

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📋 Eligibility rules (as published)
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
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What it tests

  • Mandibular Oral Repositioning Appliance
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Where

1 site
Canadian Sport Institute Alberta
Calgary, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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