Apnea Guard is a patented non-custom oral appliance that can be fitted in less than 15 minutes by any trained health professional and worn for up to 30 nights. The patented design utilizes a combination of tongue size and sex to select phenotypical features that achieve treatment outcomes superior to the conventional fitting of custom oral appliances.

Apnea Guard was developed as a result of a $1.05 mm NIH grant investigation into how to improve oral appliance therapy outcomes. Research conducted with the Apnea Guard recently received a Clinical Excellence Award and two Clinical Research awards from the American Academy of Dental Sleep Medicine.

The Apnea Guard Theragnostic Protocol explains how the feature characteristics that contributed to its superior efficacy can be digitally scanned and incorporated into custom oral appliance.  

Features
  • 1mm incremental advancements across full range of protrusive settings
  • Three vertical sizes (low, med, high VDOs) proven to improve outcomes in men and women
  • Systematic approach which predicts the target end-point for 80% of OAT responders
Clinical Applications
  • Inexpensively identify responders to oral appliance therapy
  • Reduce OSA symptoms identified post-operatively

Key Findings

Study 1
  • 79% of patients intolerant of CPAP exhibited a treatment response to the Apnea Guard
  • If a patient has an AHI < 10 with the Apnea Guard, the odds of custom oral appliance achieving an AHI < 10 is 4.3
  • Using the Theragnostic Protocol, the Apnea Guard Trial appliance delivered superior treatment outcomes as compared to a conventional fitted custom oral appliance
Study 2
When the custom oral appliance (OA) was fitted to the Trial OA/AG functional settings:
  • The custom OA was no longer inferior to the AG, the treatment responses were now essentially equivalent.
  • The treatment efficacy achieved with the AG was the only variable that predicted the custom-OA treatment outcome for three different endpoints.

Practice Benefits

Bite Registration

The Apnea Guard design features can be easily and accurately incorporated into the fabrication of the custom appliance based on one of two techniques:
With a Digital Scanner
Without a Digital Scanner

Get Started for Only $375

  • 5 AG Appliances (1 Low, 3 Med, 1 High)
  • 400g Base and Catalyst (enough to fit over 35 Apnea Guards)
  • Retention Material Scoop
  • Work Table
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Learn more about our Personalized OSA Treatment Protocol

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Technical Details and Manuals

Theragnostic Protocol
12-min Instructional Video
Technical Manual
English
Italian
Spanish

Clinical Evidence

Featured Article

Validation of a Novel Trial Oral Appliance Protocol vs. a Conventional Custom Oral Appliance Protocol for the Treatment of OSA. Levendowski DJ, Sall E, Morgan T, et al.  J Den Sleep Med. 2021;8(2)

Peer reviewed Journal Articles
Criteria for oral appliance and/or supine avoidance therapy selection based on outcome optimization and cost-effectiveness. Levendowski DJ, Olmstead R, Sall E, et al.  J Med Econ, 2021; 24(1) 757-763.
Validation of a Novel Trial Oral Appliance Protocol vs. a Conventional Custom Oral Appliance Protocol for the Treatment of OSA. Levendowski DJ, Sall E, Morgan T, et al.  J DenSleep Med. 2021;8(2)
Initial Evaluation of a Titration Appliance for Temporary Treatment of Obstructive Sleep Apnea. Levendowski D, Morgan T, Westbrook P. J Sleep Disord Ther 2011; 1:1.
Treatment Outcomes of Mandibular Advancement Devices in Positional and Non-Positional Patients. Chung JW, Enciso R, Levendowski DJ etal. Surg Oral med Oral Pathol Oral Radiol Endod,2010; 109(5),724-731. Voted by Editorial Board for H. Dean Millard BestPaper Award for 2010
Positional vs. Non-Positional Obstructive Sleep Apnea Patients; a Retrospective Study of Risk Factors associated with Apnea- Hypopnea Severity; Chung JW, Enciso R, Levendowski DJ et al. Surg Oral med Oral Pathol Oral Radiol Endod, 2010; 110:605-610.
A comparison between auto-scored apnea-hypopnea index and oxygen desaturation index in the characterization of positional obstructivesleep apnea. Levendowski DJ, Hamilton GS, St. Louis EK, et al. Nat Sci Sleep 2019; 11;69-78.
Conference Proceedings
Selection of Custom Oral Appliance Fabrication Settings Impact Treatment Efficacy.  Levendowski DJ, Sall E, Lane B, et al. World Sleep Congress, 2022, Rome Italy.
Comparison of Efficacy from a Custom and Trial Oral Appliance. Morgan T, Munafo D, Clark SJ et al. ConferenceProceeding of the American Academy of Dental Sleep Medicine, 2019, SanAntonio, Tx, AADSM Clinical Research Award recipient
Comparison of Mandibular Repositioning Device Outcomes forthe Treatment of Obstructive Sleep Apnea Using Alternative Approaches forDetermining the Optimal Jaw-Forward Position. Morgan T, Myers, A, Melzer V. Conference proceeding of American Academy of Dental SleepMedicine, 2014; Minneapolis, MN
Assessing Changes in the AHI Resulting from Increased Vertical Dimension of Occlusion (VDO) of Mandibular Repositioning Devices.  Levendowski D, Popovic D,Morgan T, Melzer V, Westbrook PR.  Sleep Breath 2009; 13:308.
Influence of Vertical Dimension on Respiratory Measures and Airway Caliber. Morgan T, Pearcy S, Scarfeo D, Levendowski D. Conference proceeding of American Academy of Dental Sleep Medicine, 2012; Boston MA
Benefit of Mandibular Repositioning Device (MRD) Therapy in Patients with Moderate and Severe OSA.  Levendowski D, Morgan T, Melzer V, Popovic D, Scarfeo D, Westbrook PR.  Sleep2009; 32:203.
Distributions of OSA Therapy Outcomes Based on a Trial Oral Appliance and/or Supine Avoidance. Levendowski DJ, Munafo D, Clark SJ et al. Conference Proceeding of the American Academy of DentalSleep Medicine, 2019, San Antonio, Tx, AADSM Clinical Research Award recipient
Therapeutic Response to Oral Appliance Therapy: Investigation of Two Criteria. Munafo D, Clark SJ, Levendowski DJ et al. Conference Proceeding of the American Academy of Dental Sleep Medicine, 2019, San Antonio, Tx
Distributions of OSA Therapy Outcomes Based on a Trial Oral Appliance and/or Supine Avoidance.  Levendowski D, Munafo D, Clark SJ et al. J Sleep Res 2019;28:S1; DOI 10.1111/jsr.72_12912
Comparison of Efficacy from a Custom and Trial Oral Appliance.  Levendowski D, Munafo D, Clark SJ et al. J Sleep Res 2019;28(S1) DOI: 10.1111/jsr.86_12913

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