BiteStrip ™ introduction

1. BiteStrip™ introduction

2. Main Sleep Disorders Overview • Sleep apnea Stops in respiration during sleep • PLMS Involuntary limb movements during sleep • Insomnia Problem in initiating and/or maintaining sleep • Bruxism Nigh time teeth grinding and clenching • Narcolepsy Sudden uncontrolled sleep spells

3. The Sleep lab • EEG • EOG • EMG (Bruxism) • ECG • Effort • Snore • Flow • Pulse oximetry • Leg movement • Esophageal pressure • Others (NPT, Video)

4. What is Bruxism • Bruxism is the forceful clenching or grinding together of the teeth • Bruxism is subconscious behavior. The patient is usually unaware of this habit • Prevalence is high (10-25%*), and decreases with age • Patients sometimes grind much harder while asleep than they can while awake • Often referred by bed-partner * Cranio. 2003 Apr;21(2):144-51. Melis M, Abou-Atme YS. Prevalence of bruxism awareness in a Sardinian population. and other sources.

5. Bruxism Damage • Enamel erosion of teeth chewing surfaces. • May result in fractured teeth and fillings • Damage to tempomandibular joints, leading to TMJ syndrome • Damage to gums and other oral structures • Sore facial muscles, headaches, and migraines • Damage to reconstructive dental work like crowns, veneers and bridges. • Low sleep efficiency, day time sleepiness

6. Some horrible pictures Bruxism is usually “diagnosed” by dentists, based on tooth attrition status. New studies show little correlation between current tooth attrition and actual Bruxism, demonstrated by EMG recordings.

7. Sleep lab Bruxism monitoring • Monitor EMG activity of jaw muscles • Count events stronger than 20-30% MVC*, longer than 0.5sec Jaw muscles contraction Bruxism =>5 events/hour Jaw muscles EMG trace *(Maximal Voluntary Clench)

8. 2 EMG electrodes (on back) Indicator light CPU and electronics Miniature 3V lithium battery Permanent electro-chemical display The BiteStrip

9. Operating principle BiteStrip tells me you need a nightguard! BiteStrip is a complete EMG recorder. Comprising two EMG electrodes, an amplifier, real-time data acquisition hardware and analysis software and a permanent display. Each bruxism episode is counted in real time. This count is used to calculate a bruxism severity index, which is presented on the digital display in the morning. * The BiteStrip: A Novel Screener for Sleep Bruxism Hadas N, Shochat T, Molotzky A, Lavie P Presented at the Chicago APSS meeting, 2001

10. Only EMG bursts stronger than threshold are counted* How BiteStrip scores an event Threshold is updated to 30% of MVC* in awake Event = EMG > 30% of MVC for more than 0.5 sec. Long events– Additional events are added for every 1.5 second in clench. *Voluntary Maximal Clench

11. BiteStrip operation • Must clean display before study for good readability • Activated by attaching green sticker on display, light blinks to mark proper activation • During first 20 minutes, light blinks with each clench. Perform two MVC to calibrate the threshold. • After 20 minutes flashing stops and actual study begins (assume patient is already asleep) • Must be on face at least 5 hours for a valid study • When removed, light will turn ON to indicate end of study • After 60 minutes display can be read after removing the green sticker, do not remove sticker sooner

12. BiteStrip Operating instructions

13. BiteStrip study timeline Light flashes until placed on face Light turns ON when removed off face Attach green sticker Activation Remove green sticker Read score After 20’, Automatically begin study Remove from face First 20‘ Perform two MVC to calibrate threshold. Light flashes with each clench. Last 30’ Calculate score and activate display 5-6 hours, but not more than 12 count clenches and grinds stronger than 30% of MVC

14. BiteStrip readout Healthy subject – less than 40 events Mild Bruxism – 41 to 74 events Moderate Bruxism– 75 to 124 events Severe Bruxism–more than 125 events Error – too short study or other problems.

15. BiteStrip performance

16. BiteStrip highlights • Only EMG recorder designed specifically for Bruxism studies. • At home study – natural sleeping environment • Good correlation with gold-standard results • Low cost – may be repeated as necessary • Easy to use, disposable • No additional equipment necessary • Instant results, small, low weight • Permanent result – save as hard copy of study

17. BiteStrip Competition • Questionnaires/Physical examination • Bruxguard reusable biofeedback device • Ambulatory sleep studies • In-lab sleep study

18. BiteStrip applications (1) • Dentists: • Check/confirm need for night-guard • Help plan/price reconstructive work • Convince patient of need for dental protection • Dental-sleep: help decide on best oral appliance for sleep apnea therapy. • Sleep labs: rule-out Bruxism due to CPAP therapy • GP: Differential diagnosis for non-specific orofacial pain/ headaches/ migraines • Dental surgeons: Screening for bruxism before implants

19. BiteStrip markets (2) • Research: epidemiological studies • Psychologists: screening for Bruxism as part of anti-stress therapy • TMJ experts: Differential diagnosis in TMJ patients • CPAP users: rule-out Bruxism due to CPAP therapy • Pain clinics: Differential diagnosis in migraine/non-specific orofacial pain patients.

20. Thank you For your time and consideration