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 • 2nd 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

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/ • ? 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, 95th 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