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John Remmers, MDChief Medical Officer, Zephyr Sleep Technologies
A New In-Lab Titration StudySelecting the Right Patients for Oral Appliance Therapy
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We start everyone on CPAP
Most patients hate it
Compliance problems
OSA TherapyWhat do we do now?
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The Alternative
Oral Appliance Therapy (OAT)
• Accounts for roughly 5% of the total OSA therapy
• Most OSA patients prefer oral appliance therapy; compliance is better
• So why are oral appliances under utilized?
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Inconsistent Efficacy
Only 50% of patients are efficaciously treated
Which ones?
Ferguson et al. SLEEP 2006; 29(2): 244-262
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Another Problem
The dentist
doesn’t know
where to set
the mandible
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Let’s sum it up
The sleep physician and
the dentist are both
operating in the dark.
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A polysomnographic mandibular titration device that:1. Selects patients for oral appliance therapy and
2. Determines an efficacious protrusive position
MATRx
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Interval 1NREM cycle; 30minsLateral PositionEffective Protrusion Mandibular position 11.0 –12.0mm
Interval 2REM cycle; 5minsLateral PositionIneffective Protrusion Mandibular position 12.4mm
Interval 3REM cycle; 25minsSupine PositionEffective Protrusion Mandibular position 13.9 –14.2mm
Interval 4REM cycle; 25minsSupine PositionEffective Protrusion Mandibular position 13.7 – 14.5mm
MATRx Study Results: PREDICTED SUCCESS; Target Protrusive Position = 14.5mmTherapeutic outcome study with oral appliance in place: AHI = 4.0
Case Study 1
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MATRx Clinical Trials
Remmers J, Charkhandeh S, Grosse J, Topor Z, Brant R, Santosham P, Bruehlmann S. Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. SLEEP 2013; 36 (10): 1517-1525.
3 prospective studies have validated MATRx
• Most recent clinical trial on 67 patients showed high predictive accuracy
See October’s issue, SLEEP
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Latest MATRx Clinical Trial
• Prospective evaluation of the predictive accuracy of MATRx
• All patients received a MATRx titration under polysomnographic monitoring
• All patients received oral appliance (SomnoDent) and were positioned at target within 3 weeks
• Sleep physician, dentist and patients blinded
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Inclusion Criteria
Broad spectrum of patients:
• Obstructive sleep apnea (AHI > 10 hr-1)
• Body mass index < 40 kg/m2
• Mean SpO2 > 90%
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Therapeutic Outcome
Success (58%) Failure
Baseline AHI(events•hr-1)
BMI (kg•m-2)
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Predicting Outcome- by Clinical Features
• Neither baseline AHI nor BMI predicted therapeutic outcome
• Adjusted neck circumference and age were weakly predictive
AHI (events•hr -1)
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Baseline | Therapy Baseline | Therapy
Predicting Outcome- by MATRx Results
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Predictive Accuracy
*Therapeutic Success defined as: AHI < 10 and 50% reduction from baseline AHI
Predicted Success*
Therapeutic Failure
Predicted Failure
Therapeutic Success
FINAL PROTRUSION
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Predictive Accuracy
*Therapeutic Success defined as: AHI < 10 and 50% reduction from baseline AHI
Predicted Success*
Therapeutic Failure
Predicted Failure
Therapeutic Success
FINAL PROTRUSION
30
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Predictive Accuracy
*Therapeutic Success defined as: AHI < 10 and 50% reduction from baseline AHI
Predicted Success*
Therapeutic Failure
Predicted Failure
Therapeutic Success
FINAL PROTRUSION
30
2
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*Therapeutic Success defined as: AHI < 10 and 50% reduction from baseline AHI
Predicted Success*
Therapeutic Failure
Predicted Failure
Therapeutic Success
FINAL PROTRUSION
30
2 24
Predictive Accuracy
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*Therapeutic Success defined as: AHI < 10 and 50% reduction from baseline AHI
Predicted Success*
Therapeutic Failure
Predicted Failure
Therapeutic Success
FINAL PROTRUSION
30
2 24
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Predictive Accuracy
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*Therapeutic Success defined as: AHI < 10 and 50% reduction from baseline AHI**PPV = 100% (with Therapeutic Success defined as: AHI < 10)
Predicted Success*
Therapeutic Failure
Predicted Failure
Therapeutic Success
FINAL PROTRUSION
30
2 24
5Sensitivity
86%
Specificity92%
PPV = 94%** NPV = 83%
Predictive Accuracy
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PPV = 87%
Predicted Success*
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TARGET PROTRUSION
*Therapeutic Success defined as: AHI < 10 and 50% reduction from baseline AHI
Therapeutic Success
Therapeutic Failure
Predictive Accuracy
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Patient Acceptance
Readily accepted; overall much better tolerated than a CPAP titration
• Trays were comfortable
• No difficulty falling asleep
• Trays did not dislodge during the study
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How does MATRx change things?
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• Informs management decisions
• Increases confidence in the efficacy of oral appliance therapy
For the Physician
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• Improves treatment efficiency with oral appliances
• Increases percentage of therapeutic successes
For the Dentist
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• Provides a true alternative to CPAP
• Improves treatment compliance, quality of life and wellness
For the Patient
