BiteStrip™ introduction

Main Sleep Disorders Overview • Sleep apneaStops in respiration during sleep

• PLMSInvoluntary limb movements during

sleep

• InsomniaProblem in initiating and/or maintaining

sleep

• BruxismNigh time teeth grinding and clenching

• Narcolepsy Sudden uncontrolled sleep spells

The Sleep lab

• EEG• EOG• EMG (Bruxism)• ECG• Effort• Snore • Flow• Pulse oximetry• Leg movement• Esophageal

pressure• Others (NPT, Video)

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.

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

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.

Sleep lab Bruxism monitoring

• Monitor EMG activity of jaw muscles• Count events stronger than 20-30% MVC*, longer

than 0.5sec

Jaw muscles

EMG trace

Bruxism =>5 events/hour

*(Maximal Voluntary Clench)

Jaw muscles

contraction

The BiteStrip 2 EMG electrodes (on back)

Miniature 3V lithium battery

CPU and electronics

Indicator light

Permanent electro-chemical display

Operating principle

* The BiteStrip: A Novel Screener for Sleep BruxismHadas N, Shochat T, Molotzky A, Lavie PPresented at the Chicago APSS meeting, 2001

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.

BiteStrip tells me

you need a

nightguar

d!

How BiteStrip scores an event

Event = EMG > 30% of MVC for more than 0.5 sec.

Long events – Additional events are added for every 1.5 second in clench.

Only EMG bursts stronger than threshold are counted*

Threshold is updated to 30% of MVC* in awake

*Voluntary Maximal Clench

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

BiteStrip Operating instructions

BiteStrip study timeline

First 20‘ Perform two MVC to calibrate threshold. Light flashes with each clench.

After 20’, Automatically begin study

5-6 hours, but not more than 12count clenches and grinds stronger than 30% of MVC

Last 30’ Calculate score and activate display

Remove green sticker

Read score

Remove from face

Attach green sticker

Activation

Light flashes until placed on face

Light turns ON when removed off face

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.

BiteStrip performance

LeftRightMann Whitn

ey

Spearman’s rho

EMG156.9 (158.7

)

146.2 (157.8)nsr=0.93, p<0.001

BiteStrip144.2 (114.8

)

130.6 (110.3)nsr=0.83, p<0.01

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

BiteStrip Competition

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

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

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.

Thank you

For your time and consideration