Sleep Apnea Screener, Sleep Apnea Tester, Disposable Sleep Apnea Screener for Obstructive Sleep Apnea

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Updated 2/23/07

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FDA Approved Disposable Sleep Apnea Screener

Prescription Required

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SLP SleepStrip sensor is a small disposable (single use) SAS screening monitor	The sensor comprises three thermal airflow sensors (two nasal and one oral), a microprocessor for real-time data acquisition, analysis hardware and software, permanent display screen and a battery.
SLP SleepStrip sensor is a complete, lightweight, wireless monitor	All the patient has to do is apply on the face and pulls out the red tab to activate.
Real-time respiration wave form analysis eliminates data memory and downloading step	Sleep apnea score is calculated automatically in the morning, according to standard scoring criteria
Sleep apnea severity is read directly off the built-in display	Data is presented in binary format; add the numbers to get the score. Two control bits assure a valid study
The SleepStrip serves as the test medical record	The display is permanent. The Sensor can be returned to the medical professional by mail.

Just look at the SleepStrip to read the results Clinical studies held in different countries and in various sleep labs have demonstrated significant correlations of 0.75-0.9 versus overnight polysomnography, as well as good sensitivity (0.70-0.88) and specificity (0.52-0.94). Published in European Respiratory Journal 2002; 19; (121-126)

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The SleepStrip as a Screener for Sleep Apnea Syndrome (SAS):
Practical Consideration

Introduction:
Based on validation studies, which compared the performance of the SleepStrip with overnight polysomnogrtaphic (PSG) recordings in clinical sleep laboratories, practical guidelines for sensible use of the SleepStrip are suggested:

1. --- The intended use of the SleepStrip is for screening purposes. It is a screening tool for the physician who needs additional information on the need for referral, and for patients who are considered high risk for SAS (including patients who are obese, hypertensive, heavy snorers and/or with a family history of SAS). If the indication of the SleepStrip is positive, together with additional indications and risk factors, patients should be referred for further evaluation.

2. --- As the SleepStrip is a screener, and not a diagnostic device, it is recommended to use a threshold Sscore >/-16. In other words, for a Sscore equal or above 16, the patient should be sent for overnight PSG recordings.

This means that:
Out of 282 patients, 154 had an AHI>10. The SleepStrip correctly identified 113 patients (73%), using the threshold Sscore >/-16.

Out of 282 patients, 104 had an AHI>20. The SleepStrip correctly identified 84 patients (81%), using the threshold Sscore >/-16

Out of 282 patients, 49 had an AHI>40. The SleepStrip correctly identified 48 patients (98%), using the threshold Sscore >/-16.

Summary:
The SleepStrip gives good sensitivity in the moderate range and excellent sensitivity in the severe range of SAS.

Together with the clinical examination and patient history, physicians can be confident with the SleepStrip that they are making the correct decision regarding further evaluation of a patient suspected of SAS.

As published in SLEEP, Vol. 23, Abstract Supplement 2, 2000: The SleepStrip: A Disposable Sleep Apnea Screening Device