Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07789834

Application of the Patient-reported Longitudinal Assessment Tool for OSA (PLATO) Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Oral Applliance Therapy Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Nevada Dental Sleep

Other

Collaborators

  • Panthera Dental

Registry information

Official study title

Application of the PLATO Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea

Acronym: APQ-OAT

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 27, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.