The Snoring Care™ System
Subject: Information concerning the new Snoring Care™ system
Intended for: Physicians and sleep experts
Presented by: Nexense, a sensor technology company, Yavne, Israel
Please spare the next few minutes to read this document carefully. It describes briefly the Snoring Care™ system, our new and innovative solution to snoring and severe snoring problems, which we believe introduces a real breakthrough in the treatment of a wide range of sleep disorders. We are sure that you may have read or heard of many other products that claimed to "solve" such problems, but as you will read below, our system provides a real solution of a completely different level.
Snoring Care™ is a friendly, simple, non-invasive and completely safe system, designed to treat snoring and related complications without any side effects. The system is based on a very sensitive sensor, developed recently by Nexense, which is used to detect, recognize and reduce snoring and related physiological activity. Once the sensor detects the breathing vibration that is typical of snoring, a feedback Utility sends a gentle feedback signal to the nervous system that imitates the sound of snoring. This unnoticed process leads the nervous system to increase the muscles tonus in the throat and as a result to open the blocked airway. The Snoring Care™ system was shown to detect snoring events as accurately as the currently used standard methods. The main advantage of Snoring Care™, however, is that it is very simple to use, it can be used at home and it does not interfere with normal sleep conditions of the user. When used properly, the system was shown to reduce snoring by up to about 75%, as measured by snoring parameters such as "snores per hour" (SPH) and "snores per series" (SPS). Representative results of a recent clinical study are shown and discussed below.
Snoring Care™ is an OTC system with a full money back guarantee. Nevertheless, in order for you to know more about the system, to be self-convinced that it is working properly and efficiently, and to feel confident to recommend to your patients to use it, we invite you to further explore the technical and clinical aspects of the system.
As an expert that might be interested in the wider area of medical sensing and monitoring, we also invite you to learn more about other Nexense innovative products, some of which are designed to measure and monitor a wide range of human vital signs (movements, heart rate, respiration rate, etc.), to detect SID, CHF and Asthma, and two new systems that are dedicated to monitor accurately a fetus during pregnancy and an "under-the-mattress" non-contact monitoring of a baby in its bed.
1. Snoring and Sleep Apnea – basic facts
Snoring is the general term associated with the vibration of respiratory structures and the resulting sound, caused due to obstructed air movement during sleep breathing.
In some cases the sound may be soft, but in other cases, it can be rather loud and quite unpleasant, and can reach sound levels of up to 60 DB. Generally, the structures involved in the sound formation are the uvula and the soft palate. The irregular airflow is caused by a passageway blockage and usually due to one or more of the following:
Throat weakness, causing the throat to close during sleep
Mis-positioned jaw, often caused by tension in the muscles
Fat gathering in and around the throat
Obstruction in the nasal passageway
The tissues at the top of airways touching each other causing vibrations
Relaxants such as alcohol or drugs relaxing throat muscles
The narrower the airway becomes, the greater the vibration and the louder the snoring. Sometimes the walls of the throat collapse completely so that it is completely occluded, creating a condition called Obstructive Sleep Apnea (OSA; cessation of breathing). It is characterized by repetitive episodes of upper airway obstruction that occur during sleep, usually associated with a reduction in blood oxygen saturation. Sleep apnea can raise lifetime risk of developing health problems such as high blood pressure, heart failure and stroke. It is estimated that 30%-50% of the people who snore on a daily basis, suffer also from Sleep Apnea. According to the Mayo Clinics, around 30% of the US 40+ population snore heavily almost every night, of which about 12,000,000 people (in the US alone) are affected by Sleep Apnea.
2. Current Solutions
Current effective solutions are the CPAP, dental devices and several types of surgical procedures including the radio frequency tissue ablation (RFTA), the laser-assisted uvulopalatoplasty, the tongue suspension procedure, coblation and several others, all of which are of limited effectiveness.
3. The Snoring Care™ solution
The Snoring Care™ is a non-invasive system, used to detect, recognize and reduce snoring and related problems. At the current version, the system includes two sensor plates (A and B), which are placed under the mattress, and a feedback unit, which is worn on the wrist.
Once the sensors detect the breathing vibration typical of snoring (above a certain level that can be adjusted on a personal basis), the feedback unit sends a gentle feedback signal to the nervous system that imitates the sound of snoring. This unnoticed process leads the nervous system to increase the muscle tonus in the throat and as a result to open the blocked airway. Preliminary studies show that the snorer feedback cycle gradually reduces the occurrence and the magnitude of snoring and thus enables a better and more effective sleep.
The Nexense non-invasive sleep laboratory
The Snoring Care™ system can also serve as a non-invasive mobile sleep laboratory, which monitors and presents the physiological information relevant for the sleep disorders including the number of snores per hour, snores per series, apnea and hypopnea events, body movements, heart rate and respiration rate. In fact, using the Nexense sleep laboratory mentioned above one can receive a full physiological report during a regular night sleep at home. It should be stressed that the sleep laboratory monitors these parameters completely passively using only two sensors that are placed under the mattress. As such, this system is non-contact, non-invasive and non-emissive, the 3-N guidelines of most of the Nexense products.
Attached is a typical report of a patient that was monitored by the Nexense sleep laboratory.
4. The Target Group
The Snoring Care™ system is designed to treat people who suffer from snoring in all levels effectively. It is especially effective for the more severe cases.
It should be noted, however, that the system is less effective in cases of alcohol or drugs consumption or in cases in which the reason for the snoring and breathing problems is a constant physical obstruction in the nasal passageway.
5. Snoring Care™ test studies
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 compliance and the efficiency of the Snoring Care™ system, as schematically outlined in the following:
a) Snoring Care™ compliance 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 Oxymeter.
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 compliance with both the ECG golden standard (Prof. 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.
The Snoring Care™ 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).
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 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 patent-pending sensor technology. If your lab or facility is interested in conducting research involving any aspect of the Nexense SoftWave technology, please contact: email@example.com.
For Further information please contact: firstname.lastname@example.org
6. 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 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 has been 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 vivid during the day after.
Preliminary Study 2: The effectiveness of Snoring Care™ to reduce sleep apnea and severe snoring.
A study involving the Snoring Care™ system proved a significant improvement in relevant sleep quality parameters.
To view the preliminary study 2 PRESS HERE
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