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Using a sleep apnea questionnaire for people treated with mouth devices

Looks at using the PLATO questionnaire in a dental sleep practice for obstructive sleep apnea.

Key facts

Who runs it
Nevada Dental Sleep
Where
Henderson, United StatesSee the site
Trial code
Registry title
Application of the Patient-reported Longitudinal Assessment Tool for OSA (PLATO) Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea
Status
Recruiting
People taking part
20 people, planned
Started
1 Oct 2026
Expected to end
Feb 2027
Type of study
Observational
Treatments tested
  • 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
Record updated
8 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with obstructive sleep apnea (breathing stops during sleep) who are treated with a custom oral appliance (mouth guard). It tests a patient questionnaire called PLATO.

Age
18 years and older
Sex
All sexes
Disease stage
AHI (breathing pauses per hour) of 5 to 30. People with AHI above 30 can join if they refuse or cannot tolerate CPAP therapy.
Earlier treatment
People must use only oral appliance therapy, with no other treatment combined. Teeth must allow use of an oral appliance.

Main reasons for not taking part

  • Pregnancy
  • Use of oxygen at home
  • Serious or uncontrolled illness, such as heart disease, cancer, stroke, dementia or chronic lung illness
  • Another significant sleep disorder
  • No smartphone for the home sleep test

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Serious/uncontrolled illness (such as angina/myocardial infarction, cancer, stroke, dementia, congestive heart failure, chronic respiratory illness), significant sleep-related disorder)
  • 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
  • Pregnancy
  • Use of home oxygen
  • The investigator feels, for any reason, that the patient's participation may not be in their best interests

Where in United States

  • Nevada Dental SleepHenderson, United StatesContact: Jerry Hu, DDS, DABDSM, DASBA, DACSDDTaking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

The PLATO questionnaire was recently developed by the American Academy of Sleep Medicine specifically for use in patients with obstructive sleep apnea.

The group in the trial

  • 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.

    Treatment: 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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Application of the PLATO Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea
Plain-language title
Using a sleep apnea questionnaire for people treated with mouth devicesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
8 October 2026