ClinicalTrials.gg
RecruitingNCT07789834APQ-OATUpdated Oct 8, 2026

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

An observational study in Obstructive Sleep Apnea (OSA) and Oral Applliance Therapy, sponsored by Nevada Dental Sleep. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Nevada Dental Sleep · Observational

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 8, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obstructive Sleep Apnea (OSA)
  • Oral Applliance Therapy

Keywords

  • Obstructive Sleep Apnea
  • Observational, Real World Study
  • PLATO Questionnaire
  • Oral Appliance Therapy
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 20 is below the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

This is the only study on the registry with Nevada Dental Sleep as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals who are referred by a qualified healthcare provider to the dental sleep clinic will be approached to participate. The community is located in Henderson, Nevada. The dental sleep clinic is a private dental sleep clinic located in a medical complex. Typically, most referrals come from within the community at large. The practice also treats individuals who are in the military (VA, active duty, special ops etc)

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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

Interventions

  • OtherThe 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.

06

What researchers measure

Primary outcomes

  1. Change from baseline of the PLATO questionnaire at the completion of the oral appliance titration period.

    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)

    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.

07

Study locations

1 of 1 sites recruiting
  • Nevada Dental Sleep
    Henderson, Nevada 89052, United States
    Recruiting
08

References and documents

Publications

  • Kirsch D, Abbasi-Feinberg F, Davies C, Gamaldo C, Thomas S, Koochaki P, Otto C, Lipman K, Rosen CL. The Patient-reported Longitudinal Assessment Tool for OSA (PLATO): development and validation of a new clinical tool to assess response to obstructive sleep apnea treatment in adults. J Clin Sleep Med. 2025 Oct 1;21(10):1743-1758. doi: 10.5664/jcsm.11790. PubMed 40465398 ↗

Individual participant data

Plan to share: No — For this study, it does not require the data to be shared.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Dec 2026, 2 months after the start.

Of 258 non-industry observational studies under Sleep Apnea, Obstructive, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 61. This study's planned 2 months is below that.

Counting every sponsor, half of 294 studies reached it within 28 months; a quarter within 14 and three quarters within 63.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 8, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Aug 27, 2026
StartActual
Oct 1, 2026was Sep 2026
Primary completionEst.
Dec 2026
CompletionEst.
Feb 2027
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 8, 2026
Sites
Nevada Dental Sleep is now Recruiting
Oct 8, 2026
Start date
Sep 2026→Oct 1, 2026 (actual)
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Not yet recruiting→Recruiting
    Nevada Dental Sleep is now Recruiting
    Start date Sep 2026→Oct 1, 2026 (now actual)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07789834
Lead sponsor
Nevada Dental Sleep
Collaborators
Panthera Dental
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Oct 1, 2026
Primary completion
Dec 2026 (estimated)
Completion
Feb 2027 (estimated)
Last update
Oct 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion