Validation of an Oral Appliance Pulse Oximeter
Summary
We are conducting a study to validate the accuracy of a pulse oximeter that is embedded into an oral appliance.
We are looking for up to 40 individuals to volunteer in a controlled desaturation (hypoxia) study, which includes visiting a dentist twice to have an oral appliance made and fitted, then wearing the appliance while you breathe gas mixtures with varying amounts of oxygen.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 50
Accepts healthy participants: Yes
Inclusion criteria:
To be eligible for the study, you must meet all of the following criteria:
1. Male or female, aged ≥ 18 and < 50 years.
2. In good health with no evidence of medical problems.
3. Ability to provide informed consent and willingness to comply with the study procedures.
4. Ability to undergo controlled hypoxemia to the levels outlined in the desaturation profile.
5. Adequate dentition for an oral appliance.
6. Ability to breathe through the nose comfortably.
Exclusion criteria:
To be eligible for the study, you may not meet any of the following criteria:
1. Body mass index > 40 kg/m2.
2. Known history of heart, lung, kidney, or liver disease.
3. Diagnosis of asthma or sleep apnea.
4. Diagnosis of diabetes.
5. Presence of a clotting disorder.
6. Presence of hemoglobinopathy or history of anemia that, in the opinion of the PI, makes the individual unsuitable for participation.
7. Current smoker.
8. History of fainting or vasovagal response.
9. History of sensitivity to local anesthesia.
10. Unacceptable collateral circulation based on exam (Allen’s test).
11. Pregnancy or lactation.
12. Resting heart rate > 120 bpm.
13. Systolic BP > 150, diastolic BP > 90.
14. Carboxyhemoglobin level > 3%.
15. Presence of any other condition that, in the opinion of the PI, makes the individual unsuitable for participation.
Participate
Fill out the following form if you want to participate in this research
Collection of personal information
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Additional information
Contact information
Dr. Marc Poulin
Principal investigator:
Marc Poulin
Clinical trial:
Yes
REB-ID:
REB23-1003