WhisperSom™ proprietary sensors and signal procesing software comprise the unique Adaptive Intelligence necessary to deliver precision, personalized acoustic neuromodulation therapy to treat snoring and sleep apnea while improving sleep.

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 studied research published 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 (CNS) without recruiting the ascending arousal system (AAS) and sympathetic nervous system (SNS) –  thereby delivering therapy without waking the patient. By comparison to prior studies, our sound files are limited to a mximum of 70 dBA and only last an instant – far quieter and briefer in duration than the sounds used in published research to-date, or a TV on in the bedroom, a ceiling fan, or other beroom sounds. Our proprietary software samples respiration signals at a much higher rate than a smartwatch or ring to deliver acoustic neuromodulation signals at the exact moment of the next breath after just one (1) missed breath regardless of sleeping position or sleep stage.

We observe that no research projects have been undertaken using WhisperSom’s proprietary approach – Adaptive Intelligence acoustic neuromodulation therapy.

This said, WhisperSom has discovered under restriction of NDA, an unpublished validation study of a prototype neuromodulation therapy device tested at Yale Gaylord Hospital. Clike HERE to view a redacted version of the study results.

WhisperSom’s intellectual property and patents pre-date and are substantially different than those of the device tested by Yale.  While the device tested by Yale used audio signals to terminate snoring and pauses in breathing as WhisperSom does, the technical approaches diverge in the following key respects.  WhisperSom™:

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 device tested by Yale
3. is a sophisticated medical-grade device which provides:
   1. the sensor sampling rate and computing power required to drive our Adaptive Intellignce 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 for those diagnosed with obstructive or central sleep apnea;
   2. is purpose-designed for wide adoption, nightly use, and economic alignment with employers and payors – delivering secure uploads of nighly sleep data to a central repository for analytics, research, product improvements, compliance tracking, and the delivery of rewards and special offers from employers and payors in return for employee/patient adoption and adherence;
   3. is far less expensive at $1,750 MSRP plus $0.99 per month for data storage after the first year vs. $1,400 – $2,300 for CPAP or BiPAP with autoserv ventilation for obstructive and central apneas, plus approx. $60 per year in replacements masks and air hoses – and FAR LESS EXPENSIVE for employers and payors than no treatment at $5,000 – $7,000 PER YEAR.

Additionally, the device tested by Yale was 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 additional data from those two sensors allow WhisperSom to use far more sophisticated signal processing.  For instance, the WhisperSom device can determine if the user is at rest or moving (asleep vs. awake), has positional obstructive sleep apnea and if yes, will act forevermore to shift the user’s sleeping position to one that leads to fewer pauses in breathing.

WhisperSom Adaptive Intelligence futher allows WhisperSom to precisely deliver therapy ONLY when needed – NOT WITH EVERY BREATH, unlike every other treatment on the market today, thus minimizing dosing.

WhisperSom believes that the development and commercialization of adaptive auditory 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 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:

• continuous exposure of cells and organs to epinephrine (aka Adrenaline®) night after night – preventing rest, building blood glucose levels and shortening life expectancy;
• large fluctuations of negative inspiratory intrathoracic pressure causing heart stress;
• large spikes in blood pressure causing heart stress;
• ventilatory overshoots causing physical stress;
• hypoxemia – blood oxygen (SpO₂) desaturation
• transient carbon dioxide (CO₂) build up

All this is to confim that it is 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.

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, encourages compliance, and:

• reduces time in apnea and hypopnea
• reducess hypoxemia (oxyheoglobin desaturation)
• reduces CO2 build-up
• reduces release of Epinephrine (aka Adreline in commercial form)
• reduces heart rate spikes and left-ventricular wall damage
• reducess excess glucose production
• reduces motion
• will determine those users who could be helped by simply being stimulated to shift to a new sleeping position (positional OSA);
• provides users and clinicians with a graphic display of data each morning that tells them how well the device is working for them, or not – encouraging compliance or an indication to seek aditional medical advice and alternative treatment;
• can be used with other treatments such as for weightloss

WhisperSom v2.5 and v6 field trials data submitted to the FDA demonstrate technical and clinical success, with no side effects. Clinical trails are planned to achieve the statistical power required to demonstrate safety and efficacy and one hundred (100) subjects will be required.