Update on Obstructive Sleep Apnea (OSA) With Oral Appliance Therapy (OAT) for the Health Care Professional

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Update on Obstructive Sleep Apnea (OSA) With Oral Appliance Therapy (OAT) for the Health Care Professional By Dr. Steven E. Todd, DMD, MaCSD, ABOI/ID

Introduction and Objectives Discuss the impact of OSA (Obstructive Sleep Apnea) Why does OSA need to be treated Approach to treatment Clinical evidence and research AASM 2015 Clinical Update and Orcades Study Co-Managed Patients with OSA & encourage continued monitoring and compliance with any and all therapies

What is OSA? Caused by a decrease in upper airway size and patency during sleep Hypercapnia and hypoxemia Repeated arousals from sleep Arousals are protective, but cause adrenalin release!!! Apnea cessation of airflow for 10 seconds or longer Hypopnea decrease in airflow lasting > 10 sec 30% reduced airflow and at least a 4% oxygen desaturation Shallow breathing; decreased minute ventilation RERA Respiratory Effort Related Arousal, doesn t meet criteria for hypopnea but is associated with an arousal

Why Obstruction Occurs During Sleep Humans have sleep apnea because we have an airway that accommodates advanced speech i.e. longer and more collapsible airway that allows us to shape sounds. Human Airway susceptible to collapse during sleep when muscles that maintain airway patency relax. Humans really only animal species that has apnea Additional factors Hormonal influences Decreased sensitivity to hypercapnia Structural variations in airway Obesity and fat deposition around airway

Classification of Sleep Apnea Apnea hypopnea index (AHI) o Number of apneas and/or hypopneas per hour of sleep (or study time) o Reflects the severity of sleep apnea o AHI = 0 5 Normal range o AHI = 5 15 Mild sleep apnea o AHI = 15 30 Moderate sleep apnea o AHI > 30 Severe sleep apnea ResMed 2014 I 5

Sleep Apnea Prevalence in Other Diseases Stroke 63% Heart Failure 76% Depression 45% Drug-Resistant Hypertension 83% Type 2 Diabetes 72% Coronary Artery Disease 57% Obesity 77% References: available upon request Prevalence A-fib 49% ResMed 2014 I

Prevalence and Challenges of Treatment More than 40 million US adults suffer from sleep-disordered breathing (SDB) o More than 85% remain undiagnosed 50% of Americans snore,1 in 5 have mild/moderate OSA, 1 in 15 have moderate/severe OSA 820,000 patients1 are noncompliant or refuse CPAP every year for various reasons; unfortunately, many patients unfortunately are unaware of alternative treatment options such as bi-pap, auto PAP or mandibular repositioning devices (MRDs). The dental channel provides alternative pathways for patients to achieve better sleep. However, the clinical pathway between MD-LAB-DME-DDS is not established. 1 US Market Deep Dive Analysis; 30% of patients referred for sleep study don t get tested; 82% of patients tested would be positive; 50% of these give the reason I don t want to use CPAP ResMed 2014 I 7

AASM 2015 Update Strengths of the 2015 Guideline Highest quality evidence published to date substantiating the use of OAs for the Treatment of primary snoring and OSA. Instructional resource for both dental and medical sleep professionals Decisions regarding type of therapy (CPAP vs OA) Expectations re: efficacy, side effects, outcomes, etc. Protocol for the best care Co-ordinated roles of sleep physician and sleep dentist Diagnosis by a sleep physician Sleep dentist evaluates patient for OA therapy, chooses and fabricates OA, and managed OA therapy Return of Patient to sleep physician for follow-up sleep study (PSG or HSAT) after OA has been adjusted Periodic recall appointments with sleep dentist Periodic recall appointments with sleep physician

AASM 2015 Update Impact on Clinical Practice Increase demand for oral appliance therapy for the treatment of snoring and obstructive sleep apnea. Increase in number of patients successfully treated with oral appliances and returning to their dental and medical professionals for periodic recall appointments Stronger relationships between dentists and sleep physicians including referral relationships establishing the model for interdisciplinary health care involving medical and dental professionals.

Call to Action!!! Medical / Dental Sleep Professionals DEVELOP Develop an integrated sleep medicine team, to include a collaborative network of local sleep physicians and dentists Recognize the vital role of oral appliance therapy in the treatment of sleep-related breathing disorders by referring to a sleep dentist problematic PAP Patient Who refuse or reject PAP Who are non-compliant or intolerant of PAP Who are inconsistently treated with PAP Refer treated patients back to the respective dentists for periodic evaluation of OA therapy Refer negative sleep study patients to a sleep dentist for treatment of their snoring problem Incorporate individual patient preference in treatment decisions (OA vs PAP) and the likelihood of adherence to therapy, short and long-term.

Three Key Trends to help us understand the current state of the Sleep Market Sleep Apnea Diabetes Screening and collaboration between healthcare providers Access to testing: PSG IN LAB HST AT HOME

AASM Practice Parameters 1 Practice Parameters for the Treatment of Snoring and Obstructive Sleep Apnea with Oral Appliances: An Update for 2015, An American Academy of Sleep Medicine Report 1 st line treatment Mild to moderate OSA (AHI 5-30) for patients who Prefer MRDs over CPAP Do not respond to CPAP Are inappropriate candidates or fail CPAP Fail behavioral measures treatment Primary snoring for patients who: Do not respond to or are inappropriate candidates for behavioral measures treatment 2 nd line treatment Severe OSA (AHI >30) in case of CPAP refusal or noncompliance 1 American Academy of Sleep Medicine Guidelines, Update 2006 ResMed 2014 I 12

Mandibular Repositioning Devices (MRD)

Treatment of OSA with a Mandibular Repositioning Device Maintains the lower jaw in a forward position during sleep. This mechanical protrusion widens the space behind the tongue, reducing the vibration and physical obstruction that cause OSA and snoring. A mandibular repositioning device (MRD) is a custom-made, prescription, adjustable oral appliance, available only from a dentist. ResMed 2014 I 14

Oral Appliance Types Mono-block articulation (TMJ) - BOIL & BITE Hinge-based articulation (TMJ and incisors) TAP MEDICARE Compression-based articulation (lower canine) HERBST MEDICARE Traction-based articulation (pre-molars and canine) Traction-based articulation (rear molars) MOSES NARVAL ResMed 2014 I 15

Center for Medicare and Medicaid Definition of Obstructive Sleep Apnea CPAP or an Oral appliance (E0486) will be covered for adults with sleep-disordered breathing if: AHI or RDI 15 or AHI or RDI 5 with ( mild, symptomatic ) Hypertension Stroke Sleepiness Ischemic heart disease Insomnia Mood disorders

OSA Why does it matter Stimulate a sympathetic response ( Fight or Flight response, Stress response) increased Sympathetic tone-increased heart rate + blood pressure, Studies have showed: Increased tonic chemoreflex drive Abnormalities in HR and BP variabilities during normal waking hours in patients with OSA Repeated stimulation during the day Increased Morbidity + Mortality Chronic increased sympathetic tone HTN, CVD and Insulin Resistance / Diabetes, Postgrad Med J 2008; 84:15-22

My Approach to OSA Treatment Explain to patient the problem and why we need to treat Stress that it s not only about how patients with sleep apnea feel, it s about reducing increased adrenergic tone! Regardless of how patients feel they need treatment Analogy of Hypertension Upon Physicians recommendation, offer oral appliance therapy Work with sleep Physicians and sleep techs to lower the patients RHI / AHI. Follow up with patient with myself and team Reassurance that together we will improve the problem Re-testing to determine level of success and decide on next step Remember everyone s a snow flake Adjuncts to therapy Good Sleep Hygiene, Circadian Alignment, Diet & Exercise, Weight Loss Others Nasal decongestion, nasal splints, ENT evaluation, positional therapy, elevation of head of bed, compression stockings.

Conventional MRD vs. Narval CC Protrusion-based articulation e.g., Herbst-like Appliance Tends to provoke mouth opening when muscles are at rest Retention-based articulation e.g., Narval CC device Tends to close mouth counter rotation strength vector will counterbalance gravity The results of the clinical studies (mouth opening, joint action) tend to show a better clinical profile in terms of compliance and side effects of devices working in traction compared to those working in compression. Souce: Chèze L. World Congress of Biomechanics 2006 ResMed 2014 I 19

ORCADES (A prospective cohort study of severe OSA patients receiving second line treatment with MRD) Efficacy: 79% success rate ( 50% decrease in AHI) irrespective of OSA severity Results: o o o o o o o 84% treatment success at 6 months Regardless of OSA severity or previous CPAP o If AHI 5-30, then AHI < 10 was 85% o If AHI 30+, then AHI < 10 was 39% ESS 11.9 to 7.9 (p<0.0001) Compliance was excellent 6.7hr / night & 6.6 nights / week Loud snoring disappeared in 90% of patients Only 4% (10pts) stopped treatment early for side effects Success metrics based on patients reaching 50% AHI reduction ResMed 2014 I 20

Narval CC Patient Selection Non-adherent CPAP patients o o o o Claustrophobic mask PAP patients Pressure sensitive PAP patients PAP holidays Combination therapy Female patients or patients with small oral cavity Patients with anterior crowns Patients with anterior sensitivity Patients with veneers Patients adverse to metallic appliances Patients with allergy restrictions Frequent travelers First line snorers ResMed 2014 I 21

2014 ResMed I 22 Narval CC Benefits and Features

Final thoughts Unique Opportunity to help patients simplify the collaboration between sleep physicians and sleep dentists. Exciting time for the sleep dentist and sleep physician to have a major impact on their patients health Need to stress the importance of OSA treatment in terms of this broader picture and not only in terms of improvement in symptoms Need to work together both sleep dentists and sleep physician, great time to learn from each other. Remember, treatment is not always easy

The Purpose in life is to collaborate for a common cause; the problem is nobody seems to know what it is. Gerhard Gschwandtner Blue Angel Medical / Dental Consulting Developing a new Paradigm in Sleep Apnea treatment

QUESTIONS? Dr. Steven E. Todd, D.M.D., ABOI\ID Credentials University of Louisville, B.A., cum laude US ARMY General Practice Residency Eisenhower Medical Center Ft. Gordon Georgia Diplomate, Board Certified, American Board Oral Implantology/Implant Dentistry Fellow, American Academy Implant Dentistry Fellow, International Congress of Oral Implantology Member, American Academy of General Dentistry University of Louisville, School of Dentistry, D.M.D. Midwest Implant Institute, Internship Oral Implantology/Implant Dentistry Columbus, OH Diplomate, International Congress Oral Implantology Fellow, Midwest Implant Institute Sedation Member, MaSCD American Society of Dental Anesthesiology Member, American Dental Association Presentation by: A2Z Computer Services, Inc., www.a2zcs.com