NCT07789834 · Nevada Dental Sleep
Application of the Patient-reported Longitudinal Assessment Tool for OSA (PLATO) Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea
(APQ-OAT)
What this study is about
forward-looking, 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 taken by mouth appliance therapy for the treatment of obstructive sleep apnea(OSA).
View original scientific description
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.
Interventions
OTHER
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
The 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.
Primary outcome measures
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Henderson, Nevada
Collaborators
Panthera Dental
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2026 · Source of record for eligibility and locations