Application of the PLATO Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change from baseline of the PLATO questionnaire at the completion of the oral appliance titration period.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Criteria
- •All ethnicities and genders
- •18 years of age
- •AHI ≥5 ≤ 30
- •Dentally suitable for OAT
- •AHI > 30 if refusal or intolerance for CPAP therapy
- •Smartphone ( for home sleep test)
- •Only using oral appliance therapy (i.e., no combination therapy)
Exclusion Criteria
- •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
- •Any condition or circumstance that, in the opinion of the investigator, is likely to preclude study completion, prevent accurate data collection, or bias the results
Arms & Interventions
Patients who have a diagnosis of obstructive sleep apnea
Patients who have been diagnosed and prescribed a custom fabricated oral appliance/mandibular advancement device (Panthera D-SAD) for the treatment of mild to moderate obstructive sleep apnea or those who are severe, who decline to use a continuous positive airway pressure (CPAP) device.
Intervention: 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)
Outcomes
Primary Outcomes
Change from baseline of the PLATO questionnaire at the completion of the oral appliance titration period.
Time Frame: The time from enrollment unit completion is as follows: Initial assessment to device delivery 10-30 days, after delivery the time depends on the participants response, which can be between 30-90 days.
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)
Secondary Outcomes
No secondary outcomes reported