Recruiting

Observational Study

Sponsor:

Nevada Dental Sleep

Code:

NCT07789834

Conditions

Obstructive Sleep Apnea (OSA)

Oral Applliance Therapy

Eligibility Criteria

Sex: All

Age: 18+

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

Study Details

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.

Conditions

Obstructive Sleep Apnea (OSA)

Oral Applliance Therapy

Study ID

NCT07789834

Start date

Oct 1, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

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 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. ]

Central Contacts and Locations

Locations

Nevada Dental Sleep

Recruiting

Henderson, Nevada, United States, 89052

Contacts

Jerry Hu, DDS, DABDSM, DASBA, DACSDD

702-478-8869office@nevadadentalsleep.com

Robyn Woidtke, MSN,RN

510-681-7923robyn.woidtke@gmail.com

Principal Investigator:

Jerry Hu, DDS, DABDSM, DASBA, DACSDD

More Information

Sponsor

Nevada Dental Sleep

Last update posted

Oct 8, 2026

Last verified

Aug, 2026

Keywords

  • Obstructive Sleep Apnea
  • Observational, Real World Study
  • PLATO Questionnaire
  • Oral Appliance Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Nevada Dental Sleep on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.