About this trial
Prospective, real-world observational study in a dental sleep practice to assess the feasibility of incorporating the PLATO into a dental sleep practice and applicability for patients who are undergoing oral appliance therapy for the treatment of obstructive sleep apnea(OSA).
The PLATO questionnaire was recently developed by the American Academy of Sleep Medicine specifically for use in patients with obstructive sleep apnea.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All ethnicities and genders
18 years of age
AHI ≥5 ≤ 30
Dentally suitable for OAT
Disqualifiers
Pregnancy
Use of home oxygen
Serious/uncontrolled illness (such as angina/myocardial infarction, cancer, stroke, dementia, congestive heart failure, chronic respiratory illness), significant sleep-related disorder)
The investigator feels, for any reason, that the patient's participation may not be in their best interests
Trial population
Individuals who are referred by a qualified healthcare provider to the dental sleep clinic will be approached to participate. The community is located in Henderson, Nevada. The dental sleep clinic is a private dental sleep clinic located in a medical complex. Typically, most referrals come from within the community at large. The practice also treats individuals who are in the military (VA, active duty, special ops etc)
Trial design
Cohort
Prospective
Treatments tested in this trial
The study will assess the feasibility of incorporating the PLATO questionnaire into a dental sleep practice. The PLATO questionnaire was developed as a patient reported outcome measure
Other interventionThe primary outcome will be to assess the difference in pre and post (within subject) scores on the PLATO questionnaire in a population of patients with a diagnosis of obstructive sleep apnea who will be treated with an oral appliance.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline of the PLATO questionnaire at the completion of the oral appliance titration period.
The PLATO questionnaire is a patient reported outcome measure. The questionnaire will be completed prior to the beginning of the therapy, until the dental practitioner, based on subjective and objective measures determine that the optimum position to treat the sleep apnea has been attained. Minimum Value: 0 Maximum Value: 50 Outcome Interpretation: Higher scores indicate a worse outcome (more severe obstructive sleep apnea symptoms and greater daytime fatigue)
Sponsors and contacts
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Nevada Dental Sleep
Lead sponsor
Panthera Dental
Collaborator