Obstructive Sleep Apnea (OSA)APQ-OATNCT07789834
Application of the Patient-reported Longitudinal Assessment Tool for OSA (PLATO) Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea (OSA) and Oral Applliance Therapy, run by Nevada Dental Sleep at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Oral Applliance Therapy
- What is being 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
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nevada Dental Sleep
Henderson, Nevada, 89052
Jerry Hu, DDS, DABDSM, DASBA, DACSDD, 702-478-8869, office@nevadadentalsleep.com
Robyn Woidtke, MSN,RN, 510-681-7923, robyn.woidtke@gmail.com
About this study
Official title: Application of the PLATO Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea
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.
- Being 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
- Keywords
- Obstructive Sleep Apnea, Observational, Real World Study, PLATO Questionnaire, Oral Appliance Therapy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 measureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Oct 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nevada Dental Sleep
- Sponsor type
- University, hospital or other
- Collaborators
- Panthera Dental
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789834
- Sponsor's protocol ID
- CS-001
- Acronym
- APQ-OAT
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For this study, it does not require the data to be shared.
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the PLATO Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07789834
- Acronym / sponsor ID
- APQ-OAT / CS-001
- Keywords
- Obstructive Sleep Apnea, Observational, Real World Study, PLATO Questionnaire, Oral Appliance Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nevada Dental SleepUniversity, hospital or other
- Collaborators
- Panthera Dental
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have a diagnosis of obstructive sleep apnea | – | 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 measurePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (7 listed)
- All ethnicities and genders
- 18 years of age
- AHI ≥5 ≤ 30
- Dentally suitable for OAT
- AHI > 30 if refusal or intolerance for CPAP therapy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 measureThe 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. | Other | Patients who have a diagnosis of obstructive sleep apnea |
Primary outcome
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.
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 40465398Kirsch 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.
- Individual participant dataSharing planned: No. For this study, it does not require the data to be shared.
Related trials for Obstructive Sleep Apnea (OSA)
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA) and Oral Applliance Therapy, run by Nevada Dental Sleep at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07789834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.