WakeZ - proof of concept pentru un supliment digital ce utilizeaza inteligenta artificiala in influentarea activitatii electrice a creierului in timpul somnului

Project Description

The overall objective of the project is to conduct research and development activities with an innovative character by the applicant, Steepsoft AI LLC, with the purpose of demonstrating the functionality of a digital system based on artificial intelligence in the field of smart specialization health - WakeZ #hackyoursleep. Through the use of a mobile phone and a smartwatch, the application will monitor and modify the brain's electrical activity during sleep by inducing subliminal stimuli in the form of vibrations, to improve sleep quality. The technology could help alleviate disorders such as sleep apnea or depression, with therapeutic effects on users' lives. Considering that the treatments currently available on the market for sleep apnea are invasive (surgical interventions) or mechanical oxygen masks that can be uncomfortable to wear during sleep, the application proposed by WakeZ #hackyoursleep has a high potential for commercialization and economic exploitation as it would not cause discomfort during use. By further increasing the technological maturity, the application developed within this project could represent the basis for a digital therapeutic for sleep apnea. Although it would not cure the disease, it would improve the quality of life and sleep of patients, delaying the point at which they become dependent on a CPAP mask.

The research and development activities to be carried out within the project will lead to an increase in technological maturity from TRL3 to TRL5, thus undergoing 2 specific stages of hypothesis validation and conceptual model testing until the project's completion.

We aim for WakeZ to be an application for smartwatches that uses subliminal stimuli in the form of vibrations to influence the brain's electrical activity with the goal of improving sleep quality. Moreover, we are investigating numerous other utilities for this technology as it matures. As features, the application could be used to help people fall asleep through breathing coaching, optimizing sleep phases through vibrations, and gradually inducing light sleep before waking up to ensure an optimal energy level upon waking and throughout the day.

At the current stage of development, our application has demonstrated the basic functionalities of the system's components, as argued in the technical document that places WakeZ at TRL3. The concept is very promising, having won the Best Product and Best Pitch awards at Innovation Labs in 2018. The validation of the innovative concept and business model has continued. Subsequently, it won the 200 Seconds of Fame competition in 2018 at the largest technology and innovation summit in Eastern and Southeastern Europe, icee.fest. In 2019, it was a winner at the EIT Health Startup Bootcamp, and in the same year, it was presented orally and as a demonstrative technology at Stanford Medicine X in California, USA, the largest innovation event in the medical field. In 2020, WakeZ received the Forbes 30 Under 30 award in Romania.

The premises for making the investment are based on empirical data provided by studies on changing brain electrical activity through neurostimulation, which have caught the scientific community's attention over the last decade. Mechanical stimulation at low frequencies between 0.25 Hz – 4 Hz is associated with a higher level of sleepiness, increased deep sleep, and improved sleep quality. Also, to feel rested, it matters not only the number of hours slept per night but also in which phase of sleep we wake up in the morning. If we wake up during REM sleep, we experience a level of fatigue that can persist throughout the day. Instead, if we wake up during an early phase of sleep, we feel more energized. Another method by which WakeZ can contribute to optimizing sleep is thus by gradually inducing light sleep before the waking time.

Regarding the utility of subliminal stimuli, studies demonstrate their capacity to improve sleep quality, both subjectively (self-evaluated by study participants) and objectively (through measuring melatonin, cortisol, body temperature). The innovation in WakeZ is that the stimuli are vibrations instead of light or sounds, thereby increasing the comfort and privacy of users.

The problem that WakeZ addresses is the widespread sleep deprivation at the population level, whether in acute episodes or chronic, poor sleep quality, daytime fatigue, and sleep disorders such as apnea. Although sleep is an activity undertaken by all people, with significant impact on physical and psychological health, there are currently no effective and scientifically validated approaches to sleep that do not involve surgical interventions, uncomfortable devices, or pharmacological products. WakeZ could represent a significantly cheaper, accessible, and easy-to-use alternative, thus having a heightened competitive advantage. Details on the competition analysis can be consulted in the Business Plan, annexed.

In conclusion, the financing of this investment is justified by:

the extremely high relevance, as it intervenes in optimizing sleep, an activity to which people allocate on average 26 years (!), according to the National Center on Sleep Disorders Research, i.e., approximately one-third of a person's life:

- the major impact of sleep on physical and psychological health, justifying investments targeting the improvement of sleep quality,

- the lack of easy-to-implement, comfortable solutions at reasonable costs and without adverse effects, non-invasive,

- empirical data showing the successful use of subliminal stimuli in improving sleep, as well as the use of smartwatches for sleep monitoring with results similar to procedures conducted in laboratories,

- the increased credibility of the product in the national and international scientific community, as demonstrated by the awards won in recent years

- the potential for development into a series of digital therapeutic products, emerging elements in health innovations

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