Clinical trial for Sleep
Official title Impact of a Mandibular Oral Repositioning Device on Sleep Quality, Heart Rate Variability, & SpO2
ClinicalTrials.gov ID: NCT07359638
What this study is testing
- What it's testing
- The study compares a jaw‑advancing oral device with a neutral placebo to see if it changes sleep stages, heart‑rate variability, and blood‑oxygen levels.
- Who it's for
- Healthy adults who have trouble sleeping or feel fatigued after sleep
- What's involved
- Participants will wear two custom‑made devices, one that gently moves the lower jaw forward and one that keeps it neutral, while a wrist‑worn monitor records sleep, heart‑rate variability, and oxygen saturation. They will also fill out short questionnaires and sleep logs.
- Time commitment
- The study lasts about 12 weeks, including a baseline period, two device phases with a washout in between, and a brief follow‑up, with regular sleep‑monitoring and questionnaire completion.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 65. Healthy volunteers may be eligible.
You may be able to join 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)
You likely can't join 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Calgary, Alberta, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.