WhisperSom Corporation uses the term “Adaptive Neuromodulation Therapy” to describe its proprietary system and method of using acoustic information and digital processing to diagnose and treat snoring and sleep apnea.

We cite evidence in our white papers documenting the efficacy of auditory stimulation using tones to produce arousals that terminate apneas without waking the patient up.  However those research projects used sine waves (approximately 0.5-4KHz) to cause those arousals. The researchers increased the amplitude of the signals during the tests in order to cause the arousals, sometimes to deafening levels. They were apparently not aware that tones are notoriously poor methods for causing a controlled arousal (see the paper titled “Children and Smoke Alarms UL Committee”). The tones they used were uni-dimensional, which while advantageous in a research environment wherein one attempts to minimize variables, are unsuitable for being adapted to subtly applying the required stimulus to produce  a non-cortical, central nervous system (CNS) arousal that causes an upper airway opening.  Indeed research has shown that stimulus reactions are unique to the individual. The problem of deriving individual specific stimulus patterns that rely only on tones are compounded, according to research which shows that there is sleep-specific dampening peculiar to inspiratory effort-related stimuli for those with OSAS.

We use research done in the field of psycho-acoustics and have designed a different approach.  The audio files we use are designed to cause a low level activation of the central nervous system and we use an adaptive algorithm so as to ”learn”  and follow the stimulus requirements of an individual for any given night as it waxes and wanes.

We must conclude that no research projects have been undertaken using our proprietary approach – adaptive auditory stimulation therapy.

This said, Dymedix appears to have conducted studies on their NMTD at the Mayo clinic which most closely resemble our approach.  Please see:

• https://clinicaltrials.gov/ct2/show/study/NCT01117064
• http://www.dailymail.co.uk/health/article-2013602/Sleep-easy-The-plaster-lip-stops-snoring.html

Those study results have not been made public.  However, Dymedix is quoted as saying,  “Our research shows that the patients are not woken and they have no memory of hearing the

sounds the following morning,” says Jim Moore (director of marketing). “They awake completely refreshed.”  Dymedix President Evan Johnston adds, “It does not wake the person

up or change the sleep state, “By sending the right type of audio signal, we can cause the airway muscles that have relaxed and obstructed breathing to regain their muscle tone.”

We are encouraged by these public statements and the fact that Dymedix appears to currently be seeking to raise $15M, albeit with the assistance of Red Oak Management Company, a company that specializes in turning around distressed, declining, or underperforming companies.  Please see: http://redoakmgmt.com/pages/projects.html

We believe that our key IP and patent applications pre-date and are substantially different than those of Dymedix.  While they use audio signals to terminate snoring and pauses in breathing before they become apneas as we do, our approaches diverge in the following key respects.  Our device:

1. does not use any face-mounted sensors, much less a “sticking plaster” on the upper lip that is also secured in place with a piece of elastic that runs around the back of the head (this “sticking plaster” is a piezo electric film sensor and will almost certainly need to be replaced on a regular basis).
2. uses Bluetooth technology to eliminate wires necessary in the Dymedix device
3. is smart phone-based which provides:
4. the computing power required to drive our adaptive, heuristic, machine learning algorithms, enabling our device to deliver the lowest amplitude signal necessary at various stages of sleep to stimulate the user to take action:  stop snoring, re-start breathing, and/or change sleeping position – assuring the best possible sleep architecture using auditory stimulation
5. secure uploads and storage of basic patient data (i.e. sex, age, height, weight, etc.) to a central repository in addition to nightly sleep data for analytics, research, product improvements, compliance tracking, the delivery of rewards and special offers from retailers, etc.
6. is intended for OTC broad consumer access and wide adoption vs. expensive sleep study + prescription
7. is far less expensive at $300 MSRP plus $5 per month vs. $1,400

Additionally, Dymedix’s device is the size of an iPhone; they do not appear to have developed a satisfactory method of attaching such an unwieldy device to the user.  It also lacks a 3-axis accelerometer and pulse oximeter.  The data from those sensors allow us to use more sophisticated processing.  For instance, WhisperSom™ will determine if the user has positional obstructive sleep apnea and will act forevermore to shift the user’s sleeping position to one that leads to fewer pauses in breathing.

We believe that the development and commercialization of adaptive auditory stimulation or neuromodulation therapy for sleep-disordered breathing is today, where CPAP therapy development was some thirty (30) years ago.  For this reason we anticipate a dearth of informed opinions from international experts about the relevance and efficacy of the technology – except from those who conducted the research projects we cite.

The most common off-the-cuff response we have encountered is, “Oh, you’re waking the patient up to get them to re-start breathing.  That will negatively impact sleep architecture and cause excessive day time sleepiness.”

In reality, those with un-treated snoring and OSA typically have arousals of varying lengths and intensities. These self-arousals, according to research, have far more adverse consequences than the short, non-cortical, CNS arousals produced in our approach such as:

• large fluctuations of negative inspiratory intrathoracic pressure;
• ventilatory overshoots;
• large spikes in blood pressure;
• greater cardiac stress; and
• SpO₂ desaturation.

All this is to say that it would appear far more advantageous for a patient who cannot tolerate CPAP, nasal valves, a mandibular advancement device, surgery or an expensive implant to receive adaptive neuromodulation therapy that produces non-cortical arousals to prevent pauses in breathing before they become apneas, than to receive that relatively violent “adrenaline shot to the heart from the brain” that otherwise naturally arouses them from the throes of an apnea or hypopnea episode.  In this connection, we expect to improve sleep architecture in addition to preventing SpO₂ desaturation in those with untreated snoring and OSA.

Within the context of the above observations together with our encouraging proof of concept results to date, we are confident that independent testing of our approach will show that our device:

• is comfortable, easy to understand, and encourages compliance
• accurately detects and terminates snoring and pauses in breathing before they become apneas
• maintains SpO₂ > 94% – all night
• will determine those users who could be helped by simply being stimulated to shift to a new sleeping position (positional OSA)
• provides users with a graphic display of data each morning that tells them how well the device is working for them, or not – encouraging compliance or seeking medical advice