Sleep Position Trainer. The best treatment for Positional OSAS

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1 Sleep Position Trainer The best treatment for Positional OSAS

2 Innovation distinguishes between a leader and a follower. - Steve Jobs

3 Positional Therapy for (P)OSAS Positional Obstructive Sleep Apnea Syndrome (POSAS) is caused by gravitational forces on the tongue, soft palate and throat, resulting in repeated collapse of the airway during sleep, reducing oxygen saturation in the blood. The severity varies per patient and determines what kind of treatment the patient requires. Supine POSAS = AHI supine > 2x AHI non-supine POSAS is defined as OSAS where the Apnea Hypopnea Index (AHI) level is at least twice as high during supine sleep compared to the AHI during sleep in all other positions. Positional Therapy with the SPT is a comfortable alternative for your patients Prevalence of POSAS patients worldwide (estimated) 80 73,4 Mio 56% 6.4% 15,7 Mio 6% 6,7 Mio of mild and moderate OSAS patients have POSAS (Richard, 2006) (X1 million) Mild AHI 5-15 Moderate AHI Severe AHI 30= (CIA, 2014; Eijsvogel, 2012; Leong, 2013; Mador, 2005) of the population is suffering from OSAS (Eijsvogel, 2012) 30% have a higher supine AHI, but not twice as high (Richard, 2006) Patient selection: For successful treatment with Positional Therapy, the following conditions should apply to your patient. Mild and moderate OSAS (AHI 5-30) Positional OSAS: AHI supine > 2x AHI non-supine Sleeping within 10-90% of the night supine Able to sleep in non-supine position (eg. no shoulder or specific back problems)

4 Sleep Position Trainer The best treatment for Positional OSAS How it works The Sleep Position Trainer (SPT) measures the sleep behavior of the patient continuously. Once the patient turns in to the supine position, this normally happens during lighter sleeping stages, the SPT gives a gentle vibration. This reminds the patient to change its sleeping position, without disrupting the natural sleep architecture. The SPT is worn in a comfortable torso strap around the upper body. In addition, the SPT comes with software to analyze the progress of the treatment. I used the SPT myself for several weeks, and found the device quite comfortable, the SPT did not negatively affect my sleep at all. - David P. White, MD Clinical Professor of Medicine, Harvard Medical School. Soft torso strap Adjustable to the body Multiple sizes Actual size (72 mm) Lightweight Freedom to move Go-to-sleep & pause mode Sleep data read-out Rechargeable battery via USB SPT Comfort Program The SPT Comfort Program helps the patient get used to sleep in a non-supine position by gradually reducing the amount of supine sleep. The first two nights the SPT only measures the sleep behavior. From the third to the tenth night, the SPT slowly builds up the amount of feedback. This improves the acceptance of the SPT by the patient. Innovative features increase comfort of the SPT Automatic personalized feedback program The SPT automatically adjusts the vibrations to the need of the patient. The feedback program contains eight different vibration levels and five different vibration patterns. Night Feedback % 100 % Analysis Build-up Position training High compliance Easy to maintain Does not disrupt sleep Limited side effects Reversible Combination therapy possible

5 I noticed a clear difference: I feel more energetic during daytime, I don t fall asleep on the couch and feel less tired while driving. - J. Homan, patient, after sleeping with the SPT for one month.

6 Proven effective 92.7% with high compliance compliant to the SPT (Van Maanen, 2013) Highest mean disease alleviation (MDA) A measure of the overall therapeutic effectiveness (Eijsvogel, 2013; Vanderveken, 2013; Grote, 2000) The SPT does not affect nor disrupt the sleep architecture of the patient (Eijsvogel, 2013; Van Maanen, 2013) SPT MRA CPAP TBT 70.5% 51.1% 50.0% 48.6% MDA % patients cured (AHI < 5) (Van Maanen, 2013) 90.5% reduction in supine sleep (Van Maanen, 2014) Effective and well-tolerated treatment for POSAS patients 68.8% reduction on total AHI (Van Maanen, 2013) With the SPT the supine sleep is reduced to an average of 3% supine sleep, this effect is maintained after six months (Van Maanen, 2014) The SPT has been clinically tested in over 35,000 nights The SPT makes other therapies more effective 52.1% improved reduction of AHI when SPT is added to a Mandibular Repositioning Appliance (MRA) treatment. (Dieltjens, 2014)

7 Read out patient data with SPT Connect software The SPT measures the sleep behavior of the patient continuously and stores the information in its internal memory. Patients can analyze the comprehensive overview of the sleep data gathered by the SPT with the use of our SPT Connect software for Windows. Physicians can easily generate sleep reports with the separate supplied software for specialists. These reports provide an overview of the effectiveness, compliance and overall progress of the treatment. Detailed overview of one night Numbers tell the tale Analyze your patient s treatment progress with our SPT Connect software Overview of one week

8 Reference: Central Intelligence Agency, CIA. The World Factbook - Population, Age structure. On Aug 20th https://www.cia.gov/ library/publications/the-world-factbook/geos/xx.html Mador MJ, Kufel TJ, Magalang UJ. Prevalence of positional sleep apnea in patients undergoing polysomnography. Chest 2005 (128): The SPT has potential to become a game changer. - Prof. dr. N. de Vries, a.o. member of guideline committees on obstructive sleep apnea. Dieltjens M, Vroegop AV, Verbruggen A, Willemen M, Verbraecken JA, van de Heyning PH, Braem MJ, de Vries N, Vanderveken OM. Effect of Sleep Position Trainer and Mandibular Advancement Devices on residual Positional Sleep Apnea under MAD therapy: a randomized clinical trial. Prevention and Research 2(3-Suppl. II) Oral Presentation, American Academy of Dental Sleep Medicine (AADSM), Baltimore, USA Eijsvogel M. Screening for OSAS in Philips employees. Oral Presentation, Nederlandse Vereniging voor Slaap-waak onderzoek (NSWO), Groningen, the Netherlands Eijsvogel M, de Jongh F, Brusse-Keizer M. Sleep Position Trainer vs. Tennis Ball Technique in positional OSA [Abstract]. Barcelona: European Respiratory Society Annual Congress 2013;42(57):3586. Grote L, Hedner J, Grunstein R, Kraiczi H. Therapy with ncpap: incomplete elimination of Sleep Related Breathing Disorder. The European respiratory journal 2000;16: Leong WB, Arora T, Jenkinson D, Thomas A, Punamiya V, Banerjee D, Taheri S. The prevalence and severity of obstructive sleep apnea in severe obesity: the impact of ethnicity. J. Clin Sleep Med 2013;9(9): Richard W, Kox D, den Herder C, Laman M, van Tinteren H, de Vries N. The role of sleeping position in obstructive sleep apnea. Eur Arch Otorhinolaryngol 2006;263: Vanderveken OM, Dieltjens M, Wouters K, de Backer WA, van de Heyning PH, Braem MJ. Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing. Thorax 2013;68:91-6. Van Maanen JP, Meester KA, Dun LN, Koutsourelakis I, Witte BI, Laman DM, Hilgevoord AA, de Vries N. The sleep position trainer: a new treatment for positional obstructive sleep apnoea. Sleep & breathing = Schlaf & Atmung 2013;17: Van Maanen JP, de Vries N. Long-term effectiveness and compliance of positional therapy with the sleep position trainer in the treatment of positional obstructive sleep apnea syndrome. Sleep 2014;37: Dieltjens M, Vroegop AV, Verbruggen AE, Wouters K, Willemen M, De Backer WA, Verbraecken JA, Van de Heyning PH, Braem MJ, de Vries N, Vanderveken OM. A promising concept of combination therapy for positional obstructive sleep apnea. Sleep Breath 2014 (ahead of print).

9 medical device class I IEC certified Product availability Check our website More information? For more information about NightBalance and our products you can contact us at or visit Molengraaffsingel 12-14, 2629JD Delft, the Netherlands NightBalance B.V.. All rights reserved.

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