AN OVERVIEW OF THE IN-LAB MATRx TITRATION SYSTEM

Selecting the Right Patients for Oral Appliance Therapy

The MATRx system integrates with the polysomnogram to allow monitoring of the patient during a customized dental titration using temporary trays.

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Oral Appliance Titration Made Simple

Perform real-time adjustments in mandibular position with the click of a mouse from the control room Evaluate airway behavior during changes in both sleep state and body position

Accurately discriminate responders from non-responders, using an evidence-based approach Confidently prescribe therapy for those patients who are responders

Improve the efficiency and confidence in oral appliance fitting by knowing the target in advance “May help reduce side effects produced by further unnecessary titration”3

The ONLY validated diagnostic device cleared by the FDA to predict therapeutic outcome with

a custom-fitted oral appliance after a single-night of study in a polysomnographic lab.

WHO SHOULD HAVE A MATRx STUDY?

The Clinical Practice Guideline for the treatment of obstructive sleep apnea (OSA) and snoring with oral appliance therapy was updated in June 2015 and published in the Journal of Clinical Sleep Medicine. The guideline expand the role of oral appliances in the treatment of OSA. 1

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Patients who are intolerant of CPAP or prefer alternate therapy 1 Patients who reject CPAP or the diagnostic study up-front Patients who refuse surgery or are not surgical candidates

Titrate remotely without disturbing your patient’s sleep

Improve patient selection for Oral Appliance Therapy

Objectively determine an effective protrusive position for the dentist

Confidently Prescribe Oral Appliance Therapy

CLINICALLY-VALIDATED, PROVEN TECHNOLOGY

3 clinical trials have been completed to date 2,8,9 Broad inclusion criteria (age 21-80, AHI > 10/hr-1, BMI < 40 kg/m2) Prospectively established predictive rules

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SIGNIFICANT ADVANCE

IN SINGLE-NIGHT TITRATION

“Overall the initial study using (MATRx) shows good accuracy in identifying

patients who will be fully treated by (an oral appliance)...as well as the likely

mandibular protrusion level.” 3

The ORANGE-Registry Update: Journal of Clinical Sleep Medicine 2014

“The MATRx study offers a clear advantage for patients and doctors by eliminating guess work in treating OSA with MRDs. We can quickly and efficiently determine optimal treatment parameters with the MATRx as part of our standard treatment protocol.”

Dr. Srujal Shah, Bay Area Dental Surgery

Therapeutic success defined as: AHI < 10 & 50% reduction from baseline AHI. * PPV = 100% with therapeutic success defined as: AHI < 10.

Predicting Therapeutic Outcome

** In patients correctly predicted to be therapeutically successful with oral appliance therapy.

Predicting Target Protrusion

Therapeutic Success Therapeutic Failure Effective Target Protrusion Position

PPV* Sensitivity NPV Specificity PPV**

CLINICAL TRIAL RESULTS ON PREDICTIVE ACCURACY 2

MATRx Study Interpretation

The following criteria2 were used to determine if the patient was a responder to mandibular advancement (i.e. a predicted success with oral appliance therapy):

Less than 2 apneas or hypopneas are present in a 5 minute window of REM supine REM lateral can be used if REM supine is not observed AND the patient is a confirmed side sleeper

MATRx STUDY ANALYSIS During the study, the patient slept reasonably well (sleep efficiency = 82%) and displayed fairly normal sleep architecture with

three REM cycles observed; two in the supine position. The arousal index was 20.3. Arterial oxyhemoglobin saturation was

normal throughout the study. One 40 minute episode of periodic limb movements was observed. The patient was a responder

to mandibular advancement in both intervals 3 and 4 (i.e. effective mandibular protrusion during REM supine was observed).

Mandibular Range of Motion Habitual Bite (Lower Limit) = 10mm

Maximum Protrusion (Upper Limit) = 17.0mm

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The patient was fitted with a SomnoDent® oral appliance adjusted to the target protrusive position. A therapeutic outcome

study, with the appliance set at this position, revealed a decrease of the AHI to a normal value of 4.0.

THERAPEUTIC OUTCOME

Understanding the MATRx Study

MATRx HYPNOGRAM

This case reveals that patients with both obesity and severe sleep apnea can be effectively treated with oral appliance therapy. Moreover, the therapeutic protrusive position can occur well short of the patient’s upper limit for mandibular protrusion.

42 year old female Baseline AHI = 41.1

BMI = 32.3

Responder to mandibular advancement in both REM supine periods (i.e. less than 2 apneas or hypopneas were observed in 5 minutes)

Interpretation

Mandibular position (mm) instead of CPAP pressure (cmH20)

Interval 2

REM cycle; 5 minutes LATERAL position Ineffective protrusion

» Mandibular position 12.4mm

The effective target protrusive position was 14.5mm (i.e. 4.5 mm of protrusion from the patient’s habitual bite)

Interval 1 NREM cycle; 30 minutes LATERAL position Effective protrusion » Mandibular position 11.0–12.0mm

MANDIBULAR TITRATION SUMMARY

Interval 3

REM cycle; 25 minutes SUPINE position Effective protrusion » Mandibular position 13.9–14.2mm

Interval 4

REM cycle; 25 minutes SUPINE position Effective protrusion » Mandibular position 13.7–14.5mm

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Sleep Physician identifies an OSA patient who may be a suitable candidate for oral appliance therapy Patient is referred to a Sleep Dentist, or trained healthcare professional, for MATRx tray preparation MATRx trays are fit to the patient’s bite and the mandibular range of motion is recorded

1 PATIENT SELECTION AND MATRx TRAY FITTING

SINGLE-NIGHT, IN-LAB TITRATION STUDY

MATRx and PSG systems are calibrated Patient’s MATRx trays are inserted in preparation for titration study Sleep Tech remotely titrates the patient’s mandibular position, in response to apneas and hypopneas, with a goal to eliminate these events during REM supine Study is scored and a PSG report is generated

Sleep Physician evaluates the MATRx study results If the patient is a responder to mandibular advancement, the patient is referred to a Sleep Dentist with an oral appliance therapy prescription, which includes the patient’s target protrusive position

Sleep Dentist uses the prescribed target protrusive position to set the patient’s therapeutic appliance to a mandibular position that will result in effective therapy

MATRx STUDY INTERPRETATION

ORAL APPLIANCE PRESCRIPTION AND FITTING

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Patient Workflow

RESEARCH & VALIDATION

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Clinical practice guideline for the treatment of obstructive sleep apnea and snoring with oral appliance therapy: an update for 2015.Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. J Clin Sleep Med 2015; 11(7): 773–827.

Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea.Remmers J, Charkhandeh S, Grosse J, Topor Z, Brant R, Santosham P, Bruehlmann S. SLEEP 2013; 36(10): 1517-25.

Oral appliance treatment for obstructive sleep apnea: an update.Sutherland K, Vanderveken OM, Tsuda H, Marklund M, Gagnodoux F, Kushida CA, Cistulli PA: on behalf of the ORANGE-Registry. J Clin Sleep Med 2014; 10(2): 215-27.

Selecting OSA patients for oral appliance therapy by mandibular protrusive titration: effect of hypopnea scoring criteria on predictive accuracy.Remmers J, Charkhandeh S, Topor Z, Grosse J, Santosham P, Bruehlmann S. In Proceedings at the 2012 SLEEP Conference (Poster Presentation, Poster Board #193; Publication Page A195, #0576). Boston, Massachusetts, June 9-13, 2012.

Target protrusive position from mandibular protrusion titration: Is it a good estimate of adequate protrusion? Does it correlate with RDI or BMI?Charkhandeh S, Topor ZL, Grosse JC, Santosham P, Bruehlmann S, Remmers JE. In Proceedings at the 21st Annual Meeting of the AADSM at the SLEEP 2012 Conference (Poster Presentation & Podium, Poster Board #001; Publication Page 29). Boston, Massachusetts, June 7-9, 2012.

Mandibular protrusion during sleep predicts outcome with oral appliance therapy of sleep apnea.Remmers J, Charkhandeh S, Topor Z, Grosse J, Bruehlmann S. In Proceedings at the ATS 2012 International Conference (Poster Presentation, Poster Board #616; Publication Page A3855). San Francisco, California, May 18-23, 2012.

Selection of patients for oral appliance therapy using mandibular protrusion during sleep.Charkhandeh S, Topor Z, Grosse J, Turner M, Remmers J. In Proceedings at the 2011 SLEEP Conference (Publication Page A117, #0331). Minneapolis, Minnesota, June 12-15, 2011.

Mandibular advancement and obstructive sleep apnea: a method for determining effective mandibular protrusion.Dort LC, Hadjuk E, Remmers JE. Eur Respir J 2006; 27(5): 1003-9.

Remotely controlled mandibular positioner predicts efficacy of oral appliances in sleep apnea.Tsai WH, Vazquez J, Oshima T, Dort LC, Roycroft B, Lowe A, Hadjuk E, Remmers JE, Am J Respir Crit Care Med 2004; 170(4): 366-70.

Manufactured by: Zephyr Sleep Technologies Inc.610A – 70th Ave. S.E. Calgary, Alberta, Canada. T2H 2J6Phone: 1 877 341 8814 www.zephyrsleep.com

OATRx™ and MATRx™ are trademarks of Zephyr Sleep Technologies Inc. All other trademarks are property of their respective holders. This product is manufactured and sold under one or more of U.S. Patent No. 5,826,579 and other U.S. and foreign patents pending.

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