ORAL APPLIANCE THERAPY

Transcription

1 ORAL APPLIANCE THERAPY IN AND OUT OF LAB Todd Wyatt, DMD

2 Background in Sleep Tim C Duke DDS Respironics SomnoMed Elite Somcenter Sleep Centers of Arkansas WCMC (Unity Health) Baptist Health ResMed American Association of Sleep Dentistry Sleep Professionals of Arkansas Over 200 active patients in treatment Experience with over twenty different mandibular advancement devices 2

3 WHY IS THERE A DENTIST HERE

4 A FEW GOOD REASONS

5 Why the AIR doesn t move Normal Airway Apnea

6 Incidence of Sleep Apnea Every 8 years, 25% of males develop sleep apnea Every 8 years 15% of females develop sleep apnea Every year, 7 million Americans develop sleep apnea 6

7 Prevalence of Sleep Apnea Last night 200 million people were apneic while they slept Current estimates of prevalence are 20% Approximately 80-90% of apneics in the USA are undiagnosed 7

8 The Questions We are always asking ourselves: How can we improve our sleep practice? Can we do a better job at meeting our OSA patient s needs? 8

9 Dealing with our Patients OSA is a medical disease A physician should prescribe treatment A physician and dentist need customized information to direct personalized, patient-centered care It s a team effort 9

10 OSA Treatment Today Variety of treatments are available which include CPAP, oral appliance therapy, lifestyle modifications and surgery CPAP is considered the treatment of choice Oral appliance (OA) therapy with a mandibular advancement device (MAD), is a viable alternative with growing use 10

11 One size does not fit all

12 AASM Guidelines Published Feb 06 Oral appliances (OAs) are indicated for use in patients with mild to moderate obstructive sleep apnea (OSA) who prefer them to continuous positive airway pressure (CPAP) therapy, or who do not respond to, are not appropriate candidates for, or who fail treatment attempts with CPAP. Practice Parameters for the Treatment of Snoring and Obstructive Sleep Apnea with Oral Appliances: An Update for SLEEP, Vol. 29, No. 2,

13 Mandibular Advancement Device Mandibular Advancement Splint MAD MAS MRD COAT

14 How the SPLINT works Oral Appliances work by reducing upper airway collapse by advancing the mandible

15 Oral Appliance Candidates? Who can wear this? Teeth are Helpful At least 10 teeth per arch is IDEAL Stable Dentition Denture Wearers Not ideal, but possible Stable Temporal Mandibular Joint Nasal Patency

16 How do you titrate? WRENCH? OR HAMMER?

17 VERY CAREFULLY

18 MELTING POT How many of these things are out there?

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20 Dorsal Fin Device SomnoDent Respire

21 Hinged Devices TAP HERBST

22 VARIATIONS EMA ResMed

23 IF YOU LOOK ON THE INTERNET IMPORTANT Secure Fit Adjustable Titrateable Holds Position Repairable AVOID One size fits most Boil and Bite Flexible adjustment arms No Warranty

24 The Problem with CPAP Poor compliance May be compromising outcomes It won t work if you don t wear it! We NEED an alternative 24

25 Two Therapies for OSA Nasal CPAP Efficacious when properly used Poorly accepted Poor compliance OA Therapy Not consistently efficacious Readily accepted Better compliance How can we decide which is best for any particular patient? 25

26 CPAP vs. OA Therapy - Where are we today? Randomized clinical trials with CPAP vs. OA therapy have yielded comparable outcomes Why? Inconsistent efficacy of OA therapy offsets the poor compliance of CPAP 26

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28 Oral Appliance Therapy - Where are we today? Accounts for roughly 5% of the total OSA therapy Overall effect on sleep-disordered breathing is inferior to CPAP OSA patients tend to favor OA therapy over CPAP OAs are easy and convenient to use and selfreported compliance is better than CPAP So why are oral appliances under-utilized? Ferguson KA. et al. Oral Appliances for Snoring and Obstructive Sleep Apnea: A Review. SLEEP 2006; 29(2): Ferguson KA. et al. Oral Appliance vs. Nasal-CPAP in the Treatment of Mild-Moderate OSA. CHEST 1996; 109:

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30 Reasons for Poor Utilization Only 50% of patients with OA therapy are effectively treated Ferguson KA et al. SLEEP 2006; 29(2): WHICH ONES? No way to identify an effective protrusive position The dentist doesn t know, in advance, where to set the mandible 30

31 Concerns with OA therapy No trial appliance or period Treatment outcome compared to CPAP Compliance: subjective vs. objective(dentitrac) Side effects (e.g. jaw discomfort, teeth movement) Patients with complicated medical history and poor dental/oral health are not good candidates Accurate patient selection 31

32 Considerations In recent studies, statistical analysis revealed no significant differences between objective and self-reported OA compliance data Objective OA compliance data will be important for reimbursement Long-term side effects of OA use should be evaluated along with the risks and health-related outcomes associated with untreated OSA CPAP mask use has also been shown to move teeth Vanderveken O et al. Objective Measurement of Compliance During Oral Appliance Therapy for Sleep Disordered Breathing. Thorax 2013; 68:

33 Health Outcomes - CPAP vs. OA Therapy Methods 126 patients with moderate-severe OSA (apnea hypopnea index [AHI], 25.6 [SD 12.3]) were randomly assigned to a treatment order and 108 completed the trial with both devices Cardiovascular, neurobehavioral and quality of life were compared between treatments Phillips CL et al. Health Outcomes of Continuous Positive Airway Pressure versus Oral Appliance Treatment for Obstructive Sleep Apnea. A Randomized Controlled Trial. Am J Resp Crit Care Med 2013; 187(8):

34 Results Health Outcomes - CPAP vs. OA Therapy CPAP was more efficacious than OA therapy Reported compliance was higher with OA therapy The 24-hour mean arterial pressure was not inferior with OA therapy compared with CPAP however, overall, neither improved blood pressure Sleepiness, driving simulator performance, and diseasespecific quality of life improved with both by similar amounts, although OA therapy was superior to CPAP for improving four general quality-of-life domains Phillips CL et al. Health Outcomes of Continuous Positive Airway Pressure versus Oral Appliance Treatment for Obstructive Sleep Apnea. A Randomized Controlled Trial. Am J Resp Crit Care Med 2013; 187(8):

35 Health Outcomes - CPAP vs. OA Therapy Conclusions In the short term, health outcomes in patients with moderate to severe OSA were similar after treatment with CPAP and OA therapy Likely explained by the greater efficacy of CPAP being offset by inferior compliance relative to OA therapy Findings strongly challenge current practice parameters recommending that OA therapy only be considered as first-line treatment in patients with mild to moderate OSA Phillips CL et al. Health Outcomes of Continuous Positive Airway Pressure versus Oral Appliance Treatment for Obstructive Sleep Apnea. A Randomized Controlled Trial. Am J Resp Crit Care Med 2013; 187(8):

36 What would the health outcomes be if we could preselect patients that would be efficaciously treated with an oral appliance? 36

37 Dr. White s Point of View Commentary on Phillips et al. Am J Resp Crit Care Med 2013; 187(8): by David P. White, MD Division of Sleep Medicine, Brigham and Women s Hospital and Harvard Medical School; Boston MA One answer would be that all OSA patients, regardless of severity, should initially be offered both CPAP and OA therapy and be allowed to choose between the two, based on personal preference. The real problem is our current inability to determine if (an oral appliance) will work in a given patient... We should use a temporary, inexpensive device (that) can be mechanically advanced during a sleep study to determine efficacy. If it is efficacious, a custom device could be fabricated and used by the patient. White DP, Continuous Positive Airway Pressure Versus the Mandibular Advancement Splint; Are They Equally Effective in Obstructive Sleep Apnea Management? Am J Resp Crit Care Med 2013 Editorial; 187:

38 The Status of OA Therapy 2014 Review Journal of Clinical Sleep Medicine 2014; 10(2): Oral Appliance Treatment for Obstructive Sleep Apnea: An Update On behalf of the ORANGE-Registry (Oral Appliance Network on Global Effectiveness) Kate Sutherland, Ph.D., Olivier M. Vanderveken, M.D., Ph.D. Hiroko Tsuda, Ph.D. Marie Marklund, Ph.D. Frederic Gagnadoux, M.D., Ph.D. Clete A. Kushida, M.D., Ph.D., F.A.A.S.M. Peter A. Cistulli, M.D., Ph.D.

39 How might we select favorable candidates for OA therapy? AHI and BMI are not reliable selection criteria Sleep apnea is not a neurological disease rather it results from an anatomic problem, i.e., structural encroachment on the pharyngeal airway which is neuraly compensated when the patient is awake In other words, any test used to determine OA candidacy should be performed when the patient is asleep (i.e. similar to an in-lab CPAP titration study) 39

40 AASM Practice Parameters for OSA treatment with oral appliances For mild-moderate OSA, OAs are first-line therapy if: Preferred over CPAP Patient does not respond to CPAP Patient is not an appropriate candidate for CPAP Patient fails CPAP For severe OSA, CPAP is first-line therapy OAs only considered if patient is CPAP intolerant Oral appliances should be fitted by qualified dental professionals who are trained and experienced in the overall care of oral health, the temporomandibular joint, dental occlusion and associated oral structures. Kushida CA. et al. Practice Parameters for the Treatment of Snoring and Obstructive Sleep Apnea with Oral Appliances: An Update for 2005; SLEEP 2006; Vol. 29, No 2. 40

41 OSA Treatment Today Despite health-related improvements, many patients reject treatment outright or only partially tolerate CPAP, limiting clinical effectiveness Best for symptomatic patients with O 2 desat Standard CPAP requires in-hospital titration Auto CPAP allows in-home initiation of therapy 41

42 In-Lab Mandibular Titration The RCMP Technology RCMP: Remote-Controlled Mandibular Positioner Previous RCMP version Dort L. et al, 2006 Current RCMP version (i.e. MATRx) Remmers J. et al,

43 MATRx A remotely-controlled mandibular protrusion device enabling physicians to: 1. Predict therapeutic outcome of oral appliance therapy in individual sleep apnea patients and 2. Prescribe the therapeutic protrusive position for the dentist 43

44 Consensus of the Experts The ORANGE-Registry identifies MATRx as a significant advance in the field Overall the initial study using this device as a prediction tool shows good accuracy in identifying patients who will be fully treated by OA as well as the likely mandibular protrusion level. Sutherland K, Vanderveken OM, Tsuda H, Marklund M, Gagnadoux F, Kushida CA, Cistulli PA; on behalf of the ORANGE- Registry. Oral appliance treatment for obstructive sleep apnea: An update. J Clin Sleep Med 2014; 10(2):

45 Who should have a MATRx study? Patients who stop using their CPAP MATRx provides an opportunity to re-engage these patients and get them back into appropriate treatment Patients who refuse PSG testing or CPAP therapy Presenting MATRx as an option may help patients decide to proceed with testing and deal with their OSA Patients referred from local dentists MATRx Sleep Centers have unmatched potential to improve the standard of care that dentists provide and grow this referral sector 45

46 Patient Workflow 46

47 MATRx System Components 47

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49 Tray Assembly

50 Tray Preparation - Sizing 2 sizes: Medium and Large

51 Impressions

52 Scale Readings Defining the Range of Motion for Titration 52

53 PSG System Integration 53

54 PSG System Requirements Processor Hard Drive RAM Video Card PSG System Requirements for MATRx Installation Intel GHz 50MB of Free Space 1GB Basic Integrated Graphics Card Operating System Windows XP, Vista, 7 DC Input V 54

55 PSG Configuration For systems with DC inputs in the PATIENT ROOM (e.g. Alice) 55

56 PSG Configuration For systems with DC inputs in the CONTROL ROOM (e.g. Sandman) 56

57 How does MATRx work? DC device Voltage signal always > 0.0V and < 1.0V 2 calibration points High voltage signal (patient s maximum protrusion) Low voltage signal (patient s habitual bite or resting position) Coordinates of the high and low calibration points will vary depending on: Each patient s mandibular range of motion Each MATRx mandibular positioner 57

58 Overview of the MATRx Study A polysomnogram (PSG) based study using temporary MATRx titration trays The goal is to eliminate apneas and hypopneas in REM sleep supine Start the study at the patient s lower limit (Habitual Bite) and titrate, in small incremental steps of 0.2mm, within the range provided by the dentist Advance the mandible in response to apneas and hypopneas RERAs and IFL not relevant to prediction criteria If possible, study the patient the supine and lateral posture, REM and NREM sleep 58

59 Study Collection - Just like CPAP 59

60 Interpretation of MATRx Data Criteria needed for predicting success with oral appliance therapy: 1 or less apnea or hypopnea 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 60

61 Interpretation Method Predicted Success Predicted Failure Inconclusive MATRx Study Definition of lateral sleep: Evidence to suggest that the patient sleeps >50% of the night in the lateral position. 61

62 MATRx Clinical Validation Case Study Review 62

63 Important Points Patient characteristics relating to OA therapy success and reliable prediction methods are a high research priority Prediction tests must be able to discriminate OA therapy responders and non-responders Predicting OA therapy responders through a sleep study using remote-controlled mandibular advancement is promising Sutherland K, Vanderveken OM, Tsuda H, Marklund M, Gagnadoux F, Kushida CA, Cistulli PA; on behalf of the ORANGE- Registry. Oral appliance treatment for obstructive sleep apnea: An update. J Clin Sleep Med 2014; 10(2):

64 Research & Validation Three prospective studies have validated the MATRx device Most recent clinical trial on 67 patients showed high predictive accuracy See October 2013 issue, SLEEP 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):

65 Latest MATRx Clinical Trial Prospective study to evaluate the predictive accuracy of a mandibular protrusion titration system (MATRx, Zephyr Sleep Technologies, Inc.) Consecutive patients recruited from sleep clinic and dental practice Sleep physician, dentist and patients blinded All patients received a MATRx titration under polysomnographic monitoring All patients received oral appliance (SomnoDent) and were positioned at target within 3 weeks 65

66 Patient Population Inclusion Criteria (Broad Spectrum) Between 21 and 80 yrs AHI > 10 hr -1 BMI < 40 kg/m 2 Neck circumference < 50 cm Mean SaO 2 > 90 % Mandibular range of motion > 5 mm Adequate dentition (i.e. 10 upper & 10 lower teeth) Baseline Characteristics Number recruited 67 Age (yrs) 51.5 Females/Males 18/ 49 BMI (kg m -2 ) 30.4 ± 4.9 AHI (events hr -1 ) 25.2 ± 14.8 SaO ± 1.4 % of time O 2 < 90% 13.4 ± 12.3 ESS 8.9 ± 5.2 Baseline Calgary SAQLI 4.6 ±

67 Inclusion Criteria All 67 participants completed the research protocol 6 MATRx studies yielded inadequate data Predictions are based on 61 participants 67

68 Therapeutic Outcome Success (58%) Failure Baseline AHI (events hr -1 ) BMI (kg m -2 ) 68

69 Predicting Outcome - by Clinical Features Baseline AHI, BMI or Positional dependence of AHI None of these, alone or in combination, predicted therapeutic outcome Adjusted neck circumference and age were weakly predictive 69

70 Predicting Outcome - by MATRx Results 70

71 Thinking outside the box Patient Selection and the Relationship of AHI to BMI AHI (events hr -1 ) BMI (kg m -2 ) 71

72 Predictive Accuracy *Therapeutic Success defined as: AHI < 10 and 50% reduction from baseline AHI **PPV = 100% (with Therapeutic Success defined as: AHI < 10) 72

73 Target Predictive Accuracy 73

74 AHI (events hr -1 ) Baseline RDI BMI (kg m -2 ) Body Mass Index Results - Protrusion Baseline AHI & BMI vs. Final Therapeutic Position % 20% 40% 60% 80% 100% 15 0% 20% 40% 60% 80% 100% Full Protrusion Full Protrusion 74

75 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 75

76 Arousals with Mandibular Movement Percent of mandibular movements associated with arousals: Sleep Stage Arousals Arousals with a Change in Sleep Stage Arousals with a Change to Wake non REM 1 24% 16% 6% non REM 2 11% 4% 1% non REM 3 13% 9% 0% REM 10% 3% 0% Totals 14% 7% 2% 76

77 Dr. Strollo s Point of View Another Advance in Oral Appliance Therapy? Commentary on Remmers et al. SLEEP 2013; 36: by Patrick J. Strollo Jr., MD, FCCP, FAASM Division of Pulmonary, Allergy, and Critical Care Medicine, UPMC Sleep Medicine Center, Pittsburgh, PA It is naive to assume that all OSA clinical phenotypes can be treated with CPAP or other forms of positive pressure alone, just as it is similarly naive to expect oral appliance therapy to be a standalone option. Personalizing care over time will require a variety of treatment options and adjustments in therapy as is the case with any chronic disease. Strollo PJ, Another Advance in Oral Appliance Therapy? SLEEP 2013 Editorial; Vol 36 (10):

78 Case Study 1 Obese Patient with Severe OSA Patient Profile 42 year old female Pre-study AHI = 41.4 BMI = 32.3 Tray Fitting Lower Limit (Resting Position) = 10.0mm Upper Limit (Maximum Protrusion) = 17.0mm 78

79 MATRx Study Results: PREDICTED SUCCESS; Target Protrusive Position = 14.5mm Therapeutic outcome study with oral appliance in place: AHI =

80 Case Study 2 Obese Patient with Moderate OSA Patient Profile 76 year old male Pre-study AHI = 17.9 BMI = 32.0 Tray Fitting Lower Limit (Resting Position) = 12.0mm Upper Limit (Maximum Protrusion) = 19.0mm 80

81 MATRx Study Results: PREDICTED FAILURE Therapeutic outcome study with oral appliance in place: AHI = 20.8

82 How does MATRx change things? Now we can offer our OSA patients a true alternative to CPAP and one that we have confidence in We can reach a new segment of OSA patients for testing (i.e. those who discontinue CPAP; those who reject CPAP or the diagnostic study up front) The sleep physician can accurately identify responders to OA therapy and prescribe a target position for the dentist The sleep dentist can improve OA treatment efficiency and increase their therapeutic success rates The sleep center can provide a new test to broaden their lab s testing capability The patient can get back into treatment and improve their overall quality of life and wellness 82

83 For more information on MATRx, please contact: Zephyr Sleep Technologies Main: Toll Free:

84 THANK YOU! Todd Wyatt, DMD 710 Marion Street, Suite 302 Searcy, AR P: (501)