apnea rx diagnostic protocol final

ApneaRx as “Predictor” in a Diagnostic Setting

Randy Clare

Respiratory Diagnostics

May, 2015

© 2015 CareFusion Corporation or one of its affiliates. All rights reserved.

Welcome

A major barrier to the widespread prescription of Oral Appliance (OA) therapy for Obsturctive Sleep Apnea (OSA) has been the inability to reliably predict treatment outcome prior to fabrication of an expensive custom-fitted device. Unlike those considering CPAP devices, which patients can “try before they buy,” those considering OA treatment must rely on the expertise of their physician in being able to predict treatment success and be willing to pay without certainty about the outcome.


Oliver M. et al. “Objective Measurement of the Therapeutic Effectiveness of Continuous Positive Airway Pressure versus Oral Appliance Therapy for the Treatment of Obstructive Sleep Apnea”, American Journal of Respiratory and Critical Care Medicine, Vol. 188, No. 9 (2013), pp. 1162-3

Who are the Patients?

• Less severe disease as well as supine-predominant OSA (a

higher AHI in supine compared to lateral sleeping position)

has been considered favorable for treatment success.

• Younger age, female gender, and less obesity (lower BMI and

neck circumference) are also suggested as indicators of

treatment success

• Consistent in all studies of OA treatment efficacy is

that OSA is not adequately alleviated in all patients.

• Individual variability in response to OA treatment represents

a significant clinical challenge, as implementing therapy in

patients who will ultimately not receive benefit is

unsatisfactory from both a treatment and cost point of view.




• Craniofacial features assessed by lateral cephalometry, including shorter soft palate length, lower hyoid bone position, greater angle between the cranial base and mandibular plane, and a retrognathicmandible, are also associated with favorable treatment outcome.

• Complete amelioration of OSA by OAm therapy can occur in severe patients and overweight patients.

• Anatomical characteristics appear to play a role in treatment outcome; however, the relatively weak and somewhat inconsistent cephalometric data suggest that decisions based solely on these factors cannot be recommended.

• Reliable prediction tests are needed in order to discriminate treatment responders and non-responders.



ApneaRx “predictor appliance”


• In this pilot study (N=117) positive predictive value of virtually 100%

• Just about every single patient who responded to a prefab OA also responded to a customized OA

• Pilot did not look at custom OSA response rates in patients who did not respond to a prefab OA, we were not able to determine the negative predictive value of using an ApneaRx as a predictor response mechanism

Dennis Hwang, Jeremiah Chang Feasibility Pilot Evaluating the Use of Pre-Fabricated Titratable Mandibular Poster Presentation AASM 2013

Combination Therapy


• CPAP and Oral Appliances

Combination Therapy

CPAP and OA users described a similar amount of side effects, although the side effect profile differed between devices. The factors most frequently mentioned that influenced choice of treatment were effectiveness, transportability, embarrassment, cost, bed partner preference, access to power supply or hot water, convenience, and impact on bite. Patient choice of treatment may be influenced by an individual's personality, lifestyle, perceived stigma, and financial status, although patients reported effectiveness of the treatment as paramount in their decision.


Sutherland K; Vanderveken OM; Tsuda H; Marlund M; Gagnadous 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):215-227.


Combination Therapy

• A pilot study of 10 patients partially treated by OAm but who failed CPAP due to intolerance to prescribed pressure, found auto-titration of CPAP pressure while wearing an OAm reduced average pressure requirement from 9.4 to 7.3. A physiological study of upper airway mechanics at various CPAP pressures delivered under conditions of (1) oronasal mask, (2) nasal mask and combined OAm, and (3) nasal mask showed that velopharyngeal resistance was reduced in the OAm/nasal mask condition compared to CPAP alone.

El-Solh AA, Moitheennazima B, Akinnusi ME, Churder PM, Lafornara AM. Combined oral appliance and positive airway pressure therapy for obstructive sleep apnea: a pilot study. Sleep Breath.

2011;15;203-8Borel JC, Gakwaya S, Masse JF, Melo-Silva CA, Series F. Impact of CPAP interface and mandibular

advancement device on upper airway mechanical properties assessed with phrenic nerve stimulation in sleep apnea patients. Respir Physiol Neurobiol. 2012;183:170-6

Sleep Apnea Diagnosis

Vital First Step

Home Sleep Test- Nox T3


Full-featured type 3 device

Lightweight and small form factor: 0.19lb with 3.11" x 2.48" x 0.83”

Standard disposable or rechargeable batteries (AA)

Intuitive analysis and reporting software

Extended applicability: pediatric, dental, cardiologist and ENT patients

Nox T3 Convincing Technology


Abdomen -Thorax respiratory effort and RIP

EtCO2 signals through wireless

Bluetooth

SpO2 and pulse from a wireless Bluetooth® oximetry

Two bipolar channels for ECG, EOG, EEG and EMG

Body position and activity

Audio recording from a built in microphone

Diagnosis


• The presence or absence of OSA must be determined before initiating treatment with oral appliances to identify those patients at risk due to complications of sleep apnea and to provide a baseline to establish the effectiveness of subsequent treatment. Detailed diagnostic criteria for OSA are available and include clinical signs, symptoms and the findings identified by polysomnography. The severity of sleep related respiratory problems must be established in order to make an appropriate treatment decision.

Kushida CA et. Al. Practice Parameters for the Treatment of snoring and Obstructive Sleep apnea with Oral appliances: An Update for 2005, SLEEP 2006;29(2);240-243

Diagnosis


• Once a satisfactory improvement in snoring and subjective OSA symptoms has taken place, the patient is referred back to the attending sleep clinician for a clinical assessment and/or repeat overnight assessment. Medical follow-up is also necessary to evaluate treatment response and to assess for recurrence of symptoms of OSA. It is recommended that a follow-up polysomnogramor an attended cardiorespiratory sleep study verify effectiveness of the OA. This recommendation is supported by the evidence from Level I, II and V studies that found some patients to have an increase in AHI with OA treatment.

Ferguson KA et. Al. oral appliance for snoring and obstructive sleep apnea: a review. Sleep. 2006 Feb; 29(2);244-62.

Treatment Success

Confirm with HST or PSG

Home Sleep Test (HST)


Scenario One…

Home diagnostics to qualify patient for Custom Oral Appliance

HST


• Provide home sleep test with Nox T3. One or Two night study.

• Board certified Sleep Physician to provide Diagnosis and treatment recommendation.

• Fabricate ApneaRx according to instructions in the package.

• Patient to wear the ApneaRx for 2 weeks.

• Provide home sleep test with Nox T3. One or Two night study.

• Board certified Sleep Physician to evaluate treatment efficacy and if indicated prescribe a custom oral appliance to be provided by a Dentist.

Polysomnogram (PSG)


Scenario Two…

PSG diagnostics to qualify patient for Custom Oral Appliance Split Night

PSG


• Board certified Sleep Physician to provide diagnosis and treatment recommendation.


• Patient sleeps for four hours to establish baseline.

• Initiate therapy, adjust the appliance in one millimeter increments every hour until patient response is confirmed.

• Board certified Sleep Physician to evaluate treatment efficacy and if indicated prescribe a custom oral appliance delivered by a Dentist.

PSG


Single-night titration methods, allowing advancement of the mandible during sleep, have shown more promise in indicating likely treatment success and therapeutic level of advancement in a small number of patients using prototype devices. This method involves use of a remotely controlled intraoral device during an attended sleep study to incrementally advance the mandible until sleep disordered breathing events are eliminated, analogous to a CPAP pressure titration study.

Sutherland K; Vanderveken OM; Tsuda H; Marlund M; Gagnadous 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):215-227.

Post Diagnosis Titration Study


Scenario Three…

• Board certified Sleep Physician to provide Diagnosis and treatment recommendation.


• Patient to wear the ApneaRx for 2 weeks.

• Retest the patient with In Lab PSG. Adjust the appliance every hour until treatment is achieved.

• Board certified Sleep Physician to evaluate treatment efficacy and if indicated prescribe a custom oral appliance delivered by a Dentist.

Bonus Slide –Treatment Success with Oral Appliances


Kate Sutherland, Ph.D.1,2; Olivier M. Vanderveken, M.D., Ph.D.3,4 Oral Appliance Treatment for Obstructive Sleep Apnea: An Update: Journal of Clinical Sleep Medicine Vol 10 No 2, 2015

Questions

Thank you

apnea rx diagnostic protocol final

Health & Medicine

oa treatment

treatment responders

carefusion corporation

severe patients

favorable treatment

overweight patients

apnearx predictor appliance

prefab oa