sleep strip & bite strip...

 

Sleep Strip

Background :

With ~80% of OSA patients still undiagnosed - effective, low-cost screening is good news.

The SleepStrip is a Disposable Sleep Apnea Screener, designed to help physicians screen patients for sleep apnea syndrome (SAS) reliably and conveniently.

The SleepStrip is, in fact, a "one-channel sleep lab" comprising signal detection, acquisition, analysis and display in one easy-to-use disposable package. SleepStrip single-use sensors provide the easiest, most advanced and cost effective method for accurate screening of SAS.

SleepStrip's accuracy has been validated by leading international decision makers.

SleepStrip is a complete all-in-one system. There's no need for additional equipment or components. Study results are read directly off SleepStrip's built-in display the morning after the study.

How SleepStrip Works

Three miniature flow sensors monitor the patient's respiration all through the night.

The integrated CPU analyzes respiration patterns to detect and count each apnea and hypopnea event as it occurs. The morning after the study the SAS severity score is calculated based on the patient's AHI and permanently displayed on the built-in electrochemical display.

Just look at SleepStrip to read the results :

• No sleep apnea - less than 15 events per hour
• Mild sleep apnea - 15 to 24 events per hour
• Moderate sleep apnea - 25 to 39 events per hour
• Severe sleep apnea - 40 or more events per hour
• Error - study too short or other problems

SleepStrip Advantages

• At-home study, in the patient's natural sleeping environment
• Easy to use, disposable, patient-applied test
• Low cost
• Accurate, good correlation with sleep lab results
• Small, lightweight, can be sent by mail
  
• Instant, permanent results, no additional equipment necessary

SleepStrip clinical studies

SleepStrip has been studied in multiple studies in many countries. Studies procedure was similar in all studies - comparing the AHI as indicated by the SleepStrip, to that derived from a formal sleep study in the sleep lab.

More studies now underway in many locations are expected to provide more confirmation.

Accuracy of the SleepStrip against lab results is measured by three factors:

• Correlation: giving a rough estimate of accuracy
  
• Sensitivity: indication what percentage of positive patients was correctly diagnosed by the SleepStrip, and
  
• Specificity: indication what percentage of negative patients was correctly diagnosed by the SleepStrip.

Sensitivity and Specificity change depending on the AHI defined as the threshold of positive indication. Most studies selected a threshold of 10, but testing the new version we have selected a value of 15 events per hour as the threshold for the positive indication, which is the currently accepted standard in the USA .

Sensitivity improves for higher threshold values (more severe patients), approaching 1 (100% chance of detection) for severe patients with AHI>50.

Bite Strip

 

Background :

Sleep Bruxism (SB) is a serious medical disorder, characterized by involuntary grinding and clenching of teeth during sleep. It is often accompanied by unpleasant grinding sounds heard by the bed-partner or roommate. Symptoms include wearing of teeth, temporomandibular joint (TMJ) dysfunction or pain, chewing difficulties, headaches and daytime sleepiness. The prevalence of SB is estimated at 14%-20% in children and 8% in adults. However, few patients are diagnosed, leaving the majority of patients to deal with the consequences of dental problems and pain that can be successfully treated. Diagnosis of SB is usually based on clinical examination and patient history. However, none of the signs and symptoms may be considered conclusive. A definitive diagnose can be obtained by a formal sleep study, costing anywhere from $600 to $1500.

Therefore, there is great demand for a simple, low cost diagnostic device, which would allow the dentist, pain expert, TMJ specialist or behavioral therapist to reliably diagnose and measure the severity of SB. This clinical information may be useful for diagnostic purposes, for monitoring treatment and for long-term follow-up.

The BiteStripT is a low cost, disposable self-use home test for SB. Its indications correlate well with comparable indications from formal sleep lab studies. It is available at a very low price to the public as a self-administered or prescription test.

The BiteStrip T can identify the existence and frequency of bruxism. This accurate, single use home screening device can be used to confidently and precisely prepare for and evaluate bruxing therapy, treatment of a malocclusion, occlusal restoration, snoring and sleep apnea treatment, and TMJ therapies and surgical outcomes.

This unique new product can help the doctor avoid costly re-work and save both chair-side time and lost revenue.

When determining an appropriate technique or the most effective material to use when planning a restorative procedure or occlusal treatment, the presence and frequency of bruxism must be considered. A patient who bruxes can destroy a costly appliance or restoration and significantly delay treatment. Screening results also serve as a basis to educate the patient about the existence of bruxing.

An alternative to formal sleep and EMG studies, the BiteStrip is a low cost, easy to use device given to a patient suspected of bruxing. The test is conducted during sleep. The BiteStrip contains a sophisticated micro CPU that operates real-time acquisition and analysis software designed to detect and count EMG signals from the masticatory muscles. A score representing a range of events is recorded on the permanent display. The score, interpreted by the doctor, indicates the existence and frequency of bruxing.

The BiteStrip unit can be included as a part of the patient's permanent medical record and used as a follow-up tool to evaluate the effectiveness of treatment as well.

BiteStrip Technology

The device is a miniature but complete sleep EMG (electromyography) monitor, including two pre-gelled EMG electrodes, an amplifier, a micro-processor-based real time data acquisition and analysis hardware and software, and a permanent chemical display unit. The entire system is integrated on a small piece of lightweight plastic film attached to the user's cheek. By analyzing the jaw muscles' EMG waveforms in real time during the night and presenting the result on the built-in display, the device doesn't need a large data memory, and the downloading and analysis phases, common to all current sleep recorders, are eliminated. Test results indicate the number of bruxing events detected per hour of sleep (bruxing index or BI). This indication appears as permanent color markers encoded onto the electro-chemical display for easy reading. The device itself can serve as the medical record of the test. Self-test markers indicate technical and clinical validity of the study.

Just look at BiteStrip to read the results :

• 0 - no bruxism: comparable to a sleep lab brux count of up to 39 over 5 hours
  
• 1 - mild: comparable to a sleep lab brux count between 40 and 74 over 5 hours
  
• 2 - moderate: comparable to a sleep lab brux count between 75 and 124 over 5 hours
  
• 3 - severe: comparable to a sleep lab brux count of more than 125 over 5 hours
  
• E - error in study

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Bite Strip Information and articles:

These articles are in Adobe pdf format. You will need the free Adobe Reader to open them. If you do not have the Reader, you may download it here.

• BiteStrip Flier
  
• Bilateral Comparisons
  
• BiteStrip - Novel Screener
  
• Detection of Sleep Bruxism in Home Studies
• Identification of Bruxism
  
• Validation of the BiteStrip

THESE DEVICES ARE NOT AVAILABLE FOR PURCHASE BY THE PUBLIC. THEY ARE DISPENSED THROUGH MEDICAL AND DENTAL OFFICES ONLYFOR EVALUATION OF APNEA AND BRUXISM.