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

NCT07789834 | Not Yet Recruiting

• 1 other identifier: CS-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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.

  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.

Study Arms (1)

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

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.

Patients who have a diagnosis of obstructive sleep apnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• \>18 years of age
• AHI 10≤ 30
• ESS ≥ 10
• Dentally suitable
• AHI \> 30 if refusal or intolerance to CPAP therapy
• Smartphone
• Oral appliance use only

You may not qualify if:

• 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 his or her 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

Sponsors & Collaborators

• Nevada Dental Sleep: lead
• Panthera Dental: collaborator

Study Sites (1)

Nevada Dental Sleep

Henderson, Nevada, 89052, United States

Location

Related Publications (1)

• 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.

  PMID: 40465398 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)