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

©ResMed 2014 I

Classification of Sleep Apnea

5

• 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

Depression

Heart Failure

Coronary

Artery Disease

Drug-Resistant

Hypertension

Obesity

Type 2

Diabetes

A-fib

76%

57%

49%

72%

77%

83%45%

Prevalence

Stroke

63%

References: available upon request

Sleep Apnea Prevalence in Other Diseases

©ResMed 2014 I

Prevalence and Challenges of Treatment

7

• 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’

AASM 2015 UpdateStrengths 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

• 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.

AASM 2015 UpdateImpact on Clinical Practice

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

©ResMed 2014 I

AASM Practice Parameters1

12

• 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

• 1st 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

• 2nd line treatment• Severe OSA (AHI >30) in case of CPAP refusal or noncompliance

1 American Academy of Sleep Medicine Guidelines, Update 2006

Mandibular Repositioning Devices (MRD)

©ResMed 2014 I

Treatment of OSA with a Mandibular Repositioning Device

14

• 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

HERBST

Oral Appliance Types

15

Compression-basedarticulation (lower canine)

MEDICARE

Traction-basedarticulation (rear molars)

NARVALMOSES

Traction-basedarticulation

(pre-molars and canine)

MEDICARE

Mono-blockarticulation

(TMJ) -

Hinge-basedarticulation

(TMJ and incisors)

BOIL & BITE TAP

Center for Medicare and MedicaidDefinition 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 Chronic increased sympathetic tone during the day HTN, CVD and Insulin Resistance / Diabetes,

• Increased Morbidity + Mortality

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.

©ResMed 2014 I

Conventional MRD vs. Narval CC

19

Souce: Chèze L. World Congress of Biomechanics 2006

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.

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

©ResMed 2014 I

Efficacy:• 79% success rate (≥50% decrease in AHI) irrespective of OSA severity

• Results:

o 84% treatment success at 6 months

o 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%

o ESS 11.9 to 7.9 (p<0.0001)

o Compliance was excellent – 6.7hr / night & 6.6 nights / week

o Loud snoring disappeared in 90% of patients

o Only 4% (10pts) stopped treatment early for side effects

o Success metrics based on patients reaching 50% AHI reduction

ORCADES (A prospective cohort study of severe OSA patients receiving second line – treatment with MRD)

20

©ResMed 2014 I

Narval CC Patient Selection

21

• Non-adherent CPAP patients

o Claustrophobic mask PAP patients

o Pressure sensitive PAP patients

o PAP holidays

o 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

© 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

Blue Angel Medical / Dental Consulting

“The Purpose in life is to collaborate for a common cause; the problem is nobody seems to know what it is.” – Gerhard Gschwandtner

Developing a new Paradigm in Sleep Apnea treatment

QUESTIONS?

CredentialsUniversity of Louisville, B.A. , cum laude University of Louisville,

School of Dentistry, D.M.D.

US ARMY General Practice ResidencyEisenhower Medical CenterFt. Gordon Georgia

Midwest Implant Institute, InternshipOral Implantology/Implant DentistryColumbus, OH

Diplomate, Board Certified,American BoardOral Implantology/Implant Dentistry

Diplomate,InternationalCongress Oral Implantology

Fellow,American AcademyImplant Dentistry

Fellow,Midwest Implant Institute

Fellow,InternationalCongress of Oral Implantology

Sedation Member, MaSCDAmerican Society of Dental Anesthesiology

Member, American Academy ofGeneral Dentistry

Member,American DentalAssociation

Dr. Steven E. Todd, D.M.D., ABOI\ID

Presentation by: A2Z Computer Services, Inc., www.a2zcs.com