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

Part of paid clinical trials in Henderson, Nevada.

Sponsor
Nevada Dental Sleep
Study ID
NCT07789834
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea (OSA)
  • Oral Applliance Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nevada Dental SleepHendersonNevada89052
Jerry Hu, DDS, DABDSM, DASBA, DACSDD
[email protected]
702-478-8869
Robyn Woidtke, MSN,RN
[email protected]
510-681-7923
Jerry Hu, DDS, DABDSM, DASBA, DACSDD (PRINCIPAL_INVESTIGATOR)

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