1. Obstructive Sleep Apnea Alternative Modes of Treatment

2. CONFLICT OF INTEREST No Financial disclosure

3. OBJECTIVES Learn about alternative treatments for OSA Learn pro and cons of these devices Learn role of these devices in patient management

4. Obstructive Sleep Apnea CONVENTIONAL TREATMENTS Positive Airway Pressure – CPAP, BPAP Oral Appliance Therapy – like TAP III Upper airway surgery – nasal turbinate reduction / septoplasty / UPPP / tongue base reduction

5. PAP Therapy Mask issues Dryness of throat / nose Aerophagia Intolerance to mask / pressure

6. Oral Appliance Therapy ? Effectiveness Tolerance issues Jaw pain Change in bite

7. Upper Airway Surgery / Nasal Surgery ? Effectiveness Anesthesia risks Post operative pain Post Nasal regurgitation (with UPPP) Recurrent OSA symptoms after few years

8. Alternative Therapies for OSA EPAP nasal resistive device Oral Pressure Therapy Hypoglossal Nerve Stimulation Maxillo-Mandibular Advancement

9. EPAP Nasal Resistive Device

10. Nasal Resistive Device http://www.proventtherapy.com/how-to-use-provent.php

11. EPAP Nasal Resistive Device: Provent Uses a device to promote positive intranasal pressure at end expiration and this maintains airway patency (expiratory resistance of 80 cm H2O/s/L at flow rate of 100 mL/s) Prototype - 24 patients with OSA and 6 primary snorers, AHI reduced 24.8 + 22.1 to 14.2+22.1 and % of TST in snoring reduced (Colrain et al JCSM 2008)(similar results - Rosenthal et al JCSM 2009) Several studies with Provent – good results, long term adherence, Predictors of success – Mallampati score of <4 – Lower baseline AHI – Lower baseline % of TST spent in O2 sat <90%

12. Provent Therapy NEGATIVE FEATURES Difficult to tailor as have fixed airway resistances Can certainly use device with variable adjustable resistance in sleep lab (similar to CPAP titration) to determine optimal resistance and then prescribing EPAP nasal device with matching resistance Pads come off spontaneously during the night FDA approved but most insurance don’t cover the cost

13. Hypoglossal Nerve Stimulation At onset of sleep apnea, there is reduction in drive to upper airway muscles (upper airway patency is strongly correlated with activation of genioglossus muscle) FDA Approved – released May 1, 2014

14. Hypoglossal Nerve Stimulation: Inspire STAR Trial Multicenter trial 126 patients with OSA (with difficulty accepting or adhering to PAP treatment) Baseline PSG (AHI 20-50); endoscopy during drug induced sleep (excluded if pronounced anatomic abnormalities or complete concentric collapse of retropalatal airway noted) Surgical procedure to implant system – stimulation electrode on hypoglossal nerve to recruit tongue protrusion function and sensing lead to detect ventilatory effort 2 nd baseline PSG one month after implantation and then device was activated Follow up at 2,6 and 12 months – clinical and PSG

15. At 12 months, AHI decreased by 68% (Median AHI 29.3 to 9.2) Oxygen Desaturation Index decreased by 70% (Median ODI score 25.4 to 7.4) Scores on FOSQ and ESS improved At end of 12 months, half group stopped stimulator, and within 1 week their AHI increased ADVERSE EFFECTS – 2 patients required device repositioning and fixation of stimulator – 18% reported temporary tongue weakness

16. Inspire Therapy Components (Implanted) – a small generator – a sensing lead – a stimulation lead. External Part - small handheld Inspire sleep remote used to turn the therapy on before bed and off upon waking. When activated, Inspire therapy senses breathing patterns and delivers mild stimulation to key airway muscles, which keeps the airway open during sleep.

17. Hypoglossal Nerve Stimulation http://www.inspiresleep.com/inspire- system.php http://www.inspiresleep.com/inspire- system.php

18. Oral Pressure Therapy http://apnicure.com/about/ Rationale – Negative pressure applied on soft palate pulls soft palate anteriorly, and stabilizes tongue to reduce obstruction during sleep Study published – 6 centers, 63 subjects- baseline PSG and repeat PSG on 1 night and 28 nights of OPT Median AHI improved from 27.5 to 14.8 ESS improved from 13 to 7 Median usage per night 6 hours

19. Oral Pressure Therapy http://apnicure.com /about/ http://apnicure.com /about/ ? Effectiveness in all patients In the study 3/63 withdrew due to oral tissue discomfort and irritation

20. Maxillo-Mandibular Advancement Creating osteotomy in maxilla and mandible to advance both of them together (+ genioglossus advancement) No change in shape of face LONG process

22. A Patient’s story Currently 46 years old Male Known OSA since 1989 (age 22) Had UPPP, tonsillectomy, nasal septoplasty prior to 2000, In 2000, PSG - AHI 116/hour On PAP – not tolerating, not benefiting Underwent radiofrequency genioplasty Using BPAP 21/17 – not tolerating well; tracheostomy recommended by ENT

23. 1st visit – 3/2012 – BMI – 37 S/N sleep study 3/2012 – – AHI 115 – Recommended BPAP 25/19; full face mask, – Poor tolerance, not sleeping well, tired, sleepy 5/2012 – tried auto titrating BPAP (average use – 3h, AHI 19, 95 th percentile pressure 24/20) Discussions regarding possible tracheostomy (he doesn’t like the idea) of maxillomandibular advancement

24. 8/2012 – 11/2012 – 12/2012

25. 2/2013 – BMI – 33; sleeping better; keeping trach capped 5/2013 – jaw wires removed 9/2013 – BMI 30.6 9/2013 – Apnea Link Plus (not using PAP device)

28. In Conclusion Newer options for patients with OSA Don’t give up and keep trying