Nexense conducted recently several studies in cooperation with leading Physicians in Israel and in the US in order to evaluate the performance of the Snoring Care™ system and its snore-reduction effectiveness. In addition, Nexense tested the new system at the homes of more than 100 snoring patients, part of them using the full sleep laboratory.
Among other key aspects, the studies examined the effectiveness and efficiency of the Snoring Care™ system, as schematically outlined in the following:
a) Snoring Care™ effectiveness and correlation with the golden standard: Since a critical part of the function of the system relies on its ability to identify accurately the number of snoring events, the respiratory profile and the heart beats, it was important to evaluate its accuracy and reliability against the "golden standard" ECG and PSG.
b) Snoring Care™ efficiency: It was important to demonstrate and validate quantitatively the improvement in common sleep indicators before and after using the Snoring Care™ including the following parameters:
- b.1.SPH (Snores Per Hour) - The number of snores detected during each sleep hour.
- b.2.SPS (Snores Per Series) - The number of snores detected in each series of snores.
- b.3.Desaturation level- The number of desaturation events (oxygen saturation levels of less than the critical threshold), as measured by an external Pulse Oxiymeter.
- b.4.REM (Rapid Eye Movement) – REM periods reflect the sleep quality and depth. It is measured through body and eye movements of the patient during sleep.
The results of the studies indicate the following conclusions:
 High Correlation with the golden standard. There is a high correlation (R² =0.95) with the ECG standard. The Snoring Care™ sensor identifies heart beats non-intrusively in an accuracy level that is in full correlation with both the ECG golden standard (Dr. Yosefi) and the common PSG monitor (see Figures 3-4 below).
Proven Effectiveness for snore reduction.
Snoring Care™ decreases the SPH (Number of Snores per Hour) by up to 75% (Figure 1) and the SPS (Snores per Series) by up to 60% (Figure 2).
- Snoring Care™ shortens the length of snores series by up to 90%.
- The number of desaturation events decreased by about 44% as a result of the significant decrease in the SPS and SPH values.
- The Snoring Care™ system does not disturb normal sleep. In fact, the results indicate an improvement in the REM sleep
- The Snoring Care™ system leads to less apnea and hypopnea events, probably as a result of the direct treatment of the snoring problems.
Additional Conclusions:
The Snoring Care™ system was shown to be very effective in snore reduction after a short "learning period" (1-2 days) and even more effective after long usage periods (2-3 weeks).
According to systematic self-reporting feed-back questionnaires, the users emphasized that they sleep better and claimed to be more alert during the next day.
The latest study which evaluated the effectiveness of the Snoring Care™ was presented in the annual ATS (American Thoracic Society) conference on May 2009. The abstract and main results are shown below.
In order to substantiate the preliminary results, Nexense is now conducting a larger and more comprehensive clinical study to evaluate the influence of the Snoring Care™ system on mild and moderate snorers and sleep apnea patients. In the near future, Nexense is planning to conduct additional clinical tests in the US and Israel, mainly in order to strengthen the preliminary results of the snoring studies and to validate the positive feedback already obtained from the Snoring Care™ users.
Snoring Care™ is currently being sold in Israel and shortly in Canada and France and complies with all necessary regulation including TUV, FCC, CE, ISO 9001 and ISO 13485.
Nexense receives an overwhelming number of research requests for its patented and patent-pending sensor technology. If your lab or facility is interested in conducting research involving any aspect of the Nexense SoftWave technology, please contact: physicians@snoringcare.com.
For Further information please contact: info@snoringcare.com
Relevant Snoring Care™ clinical studies
Preliminary Study 1: The effectiveness of Snoring Care™ to reduce severe snoring.
A clinical study involving the Snoring Care™ system was recently conducted by Dr. Ilan Gur and presented in the annual meeting of the ATS (May 2009). It proved a significant snore reduction (of up to 75%), as evaluated by parameters such as the SPH (Snores per Hour) and the SPS (Snores per Series), while improving the level of desaturation and the REM sleep.
This study was carried out on each of the volunteers at their own beds at home, for a period of 8-14 days, recording their snoring and related sleeping patterns before using the Snoring Care™ system (2-4 nights), while using the system (4-6 nights), and after using the system (2-4 nights).
The magnitude of the snoring and related problems was recorded, stored and analyzed in terms of Snores per Hour (SPH) and Snores per snoring Series (SPS). In both parameters a significant reduction was demonstrated while using the x system, and found to be in a good correlation with higher levels of oxygen saturation (less oxygen desaturation periods) and longer periods of REM and deep sleep (stages S3 and S4).
The system was shown to be more effective in snore reduction after a short "learning period" (1-2 days) and indicated to be even more effective after long usage periods (2-3 weeks). In systematic feed-back questionnaires, all the users suffering from snoring and related problems emphasized that they sleep better and claimed to be more alert and awake during the day after.
Figure 1 – Snoring Care™ influence on snores per hour
Figure 2 – Snoring Care™ influence on the length of snores
Figure 3 - Comparison between Snoring Care™ Sensors Results and Golden Standard Sensors
Conducted by Dr Blonder – 2008
Figure 4 - Comparison between Sensors Results Of Snoring Care™
and PSG Golden Standard for respiratory monitoring
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