Snoring, Obstructive Sleep Apnea (OSA) and their treatment with oral appliance Soteria Biotech

Snoring and OSA  Snoring is produced by obstruction of air movement during breathing while sleeping  Snoring during sleep may be the first sign of OSA  OSA is the most common types of sleep apnea, it is caused by partial or complete obstructed upper airway

Diagnosis of OSA  Diagnosis is based on patient history and test results

 Gold standard test is polysomnography (PSG)  brain waves (electroencephalogram, or EEG);  eye movements (electrooculogram, or EOG);

 chin muscle activity (chin electromyogram, or EMG);  air flow from the nose and mouth;  chest and abdominal movement;

 blood oxygen levels (oximetry);  heart rate and rhythm (electrocardiogram, or ECG);  and leg movements (leg electromyogram, or EMG).

Diagnosis of OSA

Diagnosis of OSA  The result of PSG is presented as Apnea Hypopnea Index (AHI)

 AHI is defined as number of apnea (complete cessation of airflow for at least 10 seconds) or hypopnea (airflow decreases by 50% for 10 seconds or decreases by 30% if there is an associated decrease in the oxygen saturation or an arousal from sleep) in an hour  Severity of OSA is classified by AHI  None/Minimal: AHI < 5 per hour  Mild: AHI ≥ 5, but < 15 per hour  Moderate: AHI ≥ 15, but < 30 per hour  Severe: AHI ≥ 30 per hour

Consequence of OSA1  Direct effect of OSA  Sleepiness, fatigue, irritability, and personality change

 Patients with OSA have an increased risk of:  Motor vehicle accident,

 Hypertension,  Nocturnal dysrhythmias,  Pulmonary hypertension,

Right and left ventricular failure,  Myocardial infarction,  Stroke

Treatment of OSA  Treatment strategies are in general grouped in to three categories:

 Behavioral  Weight loss, stop taking alcohol, sedatives and hypnotics

 Medical  Continuous Positive Airway Pressure (CPAP), Oral Appliance (OA)

 Surgical  Uvulopalatopharyngoplasty (UPPP), Maxillomandibular Advancement

Oral Appliance for snoring and OSA  Non-invasive

 Recommended by many sleep organization worldwide*  Effective in treatment of snoring and mild to moderate OSA2  High patient adherence rate of 77% over one year2

 No known adverse effect3  Easy to use  Convenient to travel

 Easy to care for  Can be used together with CPAP

*American Academy of Dental Sleep Medicine; American Academy of Sleep Medicine; Sleep Health Foundation (Australia); Australasian Sleep Association; Sleep Disorders Australia

Current method of making an effective OA 1. Patient’s dental impression

2. Dental cast/mold made from the dental impression 3. OA made from the dental cast/mold 4. Dentist fits OA on patient and make an adjustment with his/her own best judgement and experience 1) This process may take several visits depending on patient’s feedback

Issues with the current method  Dentist can not see patient’s anatomical condition while making the adjustment on OA  It is impossible to know if the most effective adjustment for the patient has been made  Patient may have to visit dentist several times before the most effective adjustment has been made

Researchers are trying to solve these issues  Several publications are trying to find the most helpful method to evaluate upper airway4,5,6,7  J.W. De Backer et al. suggested that outcome of OA treatment could be predicted by using imaging plus computational fluid dynamics4  J.W. De Backer et al. published a review paper where he examined eight papers related to using computer methods to evaluate upper airway, the result indicate using imaging and computer methods can predict clinical outcome after treatment5

 C. Van Holsbeke et al. published a study on anatomical and functional changes in upper airway of OSA patients using OA by using imaging and computational fluid dynamics6

Researches are trying to solve these issues  M. Zhao et al. uses computational fluid dynamics and imaging technique to evaluate upper airway response to OA treatment7  Medical imaging and Computational Fluid dynamics are tools used in these researches to evaluate upper airway conditions

Research involvement  Involved in the research with computational fluid dynamics studies with obstructive sleep apnea8 and maxillomandibular advancement9

Soteria OA technology  Uses the same methodology to evaluate patient’s upper airway as the referenced publications  Gone a step further by giving the most effective adjustment on OA

Automatic Process

Results

CT Images Select upper airway

Internet

3D model reconstruction and CFD simulation

The most effective adjustment

Storage Super Computer

Dentists

Soteria OA technology – Case  Mr. M decided to use oral appliance to treat his snoring problem  Using Soteria OA technology to scan and evaluate Mr. M’s upper airway

Narrow upper airway

Result shows increased pressure (red area) at the upper airway; a sign of obstruction

Soteria OA technology – Case  Using Soteria OA technology to scan and evaluate Mr. M’s upper airway while wearing customized oral appliance

Result shows no pressure difference, airway is patent Upper airway patent

Business model Visit Patient Revisit

Patient’s dental impression (2 days)

Send oral appliance (2 days)

Technician (Make oral appliance 7 days)

Radiography center (CT scan)

Dental Clinic

Soteria • Oral appliance material • Patient’s dental impression • Optimum adjustment distance

Upload DICOM file

References 1.

Strollo P., Rogers R. Obstructive Sleep Apnea. N Engl J Med 1996;334:99-104

2.

Ferguson K., Cartwright R., Rogers R., Schmidt-Nowara W. Oral Appliances for Snoring and Obstructive Sleep Apnea: A Review. SLEEP 2006;29(2):244-262

3.

Ringqvist M., Walker-Engstro M.L., Tegelberg A., Ringqvist I. Dental and skeletal changes after 4 years of obstructive sleep apnea treatment with a mandibular advancement device: A prospective, randomized study. Am J Orthod Dentofacial Orthop 2003;124:53-60

4.

De Backer J.W., Vanderveken O.M., Vos W.G., Devolder A., Verhulst S.L., Verbraecken J.A., Parizel P.M., Braem M.J., Van de Heyning P.H., De Backer W.A. Functional imaging using computational fluid dynamics to predict treatment success of mandibular advancement devices in sleep-disordered breathing. Journal of Biomechanics 2007;40:3708–3714

5.

De Backer J.W., Vos W.G., Verhulst S.L., De Backer W.A. Novel imaging techniques using computer methods for the evaluation of the upper airway in patients with sleep-disordered breathing: A comprehensive review. Sleep Medicine Reviews 2008;12:437-447

6.

Van Holsbeke C., De Backer J.W., Vos W.G., Verdonck P., Van Ransbeeck P., Claessens T., Braem M., Vanderveken O.M., De Backer W.A. Anatomical and functional changes in the upper airways of sleep apnea patients due to mandibular repositioning: A large scale study. Journal of Biomechanics 2011;44:442–449

7.

Zhao M., Barber T., Cistulli P, Sutherland K., Rosengarten G. Computational fluid dynamics for the assessment of upper airway response to oral appliance treatment in obstructive sleep apnea. Journal of Biomechanics 2013;46:142–150

8.

Yu C., Hsiao H., Tseng T., Lee L., Yao C., Chen N., Wang C., Chen Y. Computational Fluid Dynamics Study of the Inspiratory Upper Airway and Clinical Severity of Obstructive Sleep Apnea. J Craniofac Surg 2012;23:401-405

9.

Yu C., Hsiao H., Lee L., Yao C., Chen N., Wang C., Chen Y. Computational Fluid Dynamic Study on Obstructive Sleep Apnea Syndrome Treated With Maxillomandibular Advancement. J Craniofac Surg 2009;20:426-430