Personalized and Adaptive kinesthetic StImulation Therapy, based on Holter monitoring, for slEep Apnea syndromes – PASITHEA

The sleep apnea syndrome (SAS) is a multifactorial disease characterized by repeated episodes of breathing pauses (apnea) or significant reduction of the respiratory amplitude (hypopnea) during the sleep of the patient. This disease affects more than 5% of the general population, but remains underdiagnosed, especially in populations "at risk" such as cardiovascular disease and type 2 diabetes, for which a SAS increases the risk of complications. In this context, the proposal of new diagnostic and therapeutic devices is a priority. Regarding the diagnostic aspect, these systems must incorporate advanced methods of information processing and be adapted to the practice of various medical specialties involved (pulmonologists, cardiologists, endocrinologists) who are not experts in sleep analysis. Concerning the treatment aspect, the reference approach is the continuous positive airway pressure (CPAP) that consists in blowing air into the upper airways via a nasal mask. This pressure increases the volume of the pharynx and prevents inspiratory collapse. The rate of initial refusal of the CPAP is 15% with 20% of the patients leaving the therapy afterwards. New treatment options have also to be developed.
The overall objective of this project is to propose a new complete system for the detection, monitoring and treatment of SAS by means of an adaptive, kinesthetic stimulation, capable of reducing the number of respiratory events, while minimizing side effects associated with micro-awakenings and the discomfort caused by current therapies, specially those based on positive pressure. The main product of this project will be a complete communicating system integrating: 1) a new cardiorespiratory Holter device, developed on the basis of an existing product of SORIN, including new sensors for hemodynamic and metabolic function; 2) methods of data processing for the detection and characterization of apnea / hypopnea episodes, exploiting the new sensors and embedded into the Holter, and 3) a new kinesthetic stimulation device, integrating an auto-adaptive control method to optimize the stimulation in a personalized way. A quantitative evaluation of the system is planned in this project, through the realization of two clinical studies. This project differs from ideas explored so far by the coupling of these diagnostic and therapeutic devices, but also by the fact of integrating an auto-adaptive control algorithm into the kinesthetic therapeutic device, to improve both the effectiveness of treatment and comfort of the patient.
Five tasks have been identified for this project. The first one (T1) is focused on project management. The second aims the creation of a new cardiorespiratory Holter. The third (T3) will focus on the kinesthetic stimulation therapy, having as main objective, to create the auto-adaptive control algorithm to optimize the therapy. Task 4 will focus on the coupling of the detection and stimulation devices and integration of the whole system. Finally, task 5 is focused on the initial evaluation of technical and clinical feasibility of the proposed system through two pilot studies, including 28 patients in each study, to be conducted at CHU Grenoble and CIC-IT in Rennes. Such an adaptive system can contribute to the shortening cycle of diagnosis-therapy, which is often long in the said population, the decrease in hospitalizations for acute decompensated heart failure patients and a reduced mortality risk. It is worth to note here that these clinical studies represent less than one third of the amount of funding requested to the ANR and that approximately 20% of costs associated with clinical studies will be supported financially by the company SORIN.