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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNevada Dental Sleep

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All ethnicities and genders

18 years of age

AHI ≥5 ≤ 30

Dentally suitable for OAT

Disqualifiers

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

Trial 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)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Patients who have a diagnosis of obstructive sleep apnea1 intervention

Trial outcomes

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nevada Dental Sleep

Lead sponsor

Panthera Dental

Collaborator