PASITHEA: An Integrated Monitoring and Therapeutic System for Sleep Apnea Syndromes Based on Adaptive Kinesthetic Stimulation

Abstract

International audienceSleep apnea syndromes are characterized by repeated episodes of breathing pauses (apnea) or significant reductions in respiratory amplitude (hypopnea) during the patient's sleep. These episodes significantly alter the sleep structure of the patient and provoke acute cardiorespiratory responses that may be deleterious in the long term. Continuous positive airway pressure (CPAP) therapy is the gold-standard treatment for SAS, but patient compliance to this therapy is low. This paper presents a new system for real-time detection, monitoring and treatment of SAS, based on triggered kinesthetic stimulation. The system is composed of 3 components: i) a cardio-respiratory recorder, ii) a kinesthetic stimulator and iii) a real-time processing application, integrating an " on-off " control method to trigger the kinesthetic stimulation as a function respiratory event detections. A preliminary evaluation of the system , performed on 46 patients suffering from severe SAS is also presented. This evaluation is focused on i) the performance characterization of the real-time respiratory event detector and ii) a qualitative description of the effect of the therapy. A satisfactory real-time respiratory event detection performance (sensitivity= 89.2%, positive predictive value = 59%) was obtained with the proposed detector, when evaluated retrospectively using the acquired data. Three case reports, describing the cardiorespiratory response to the therapy of a responder, a partially-responder and a non-responder patients ar

Letter to the editor of “Sleep Medicine” regarding the publication entitled “Acoustic stimulation time-locked to the beginning of sleep apnea events reduces oxygen desaturations: a pilot-study”, by Waeber et al

“…The kinesthetic stimulation is performed on the mastoid region, using a stimulation signal that has been optimized (within the audible frequency band) in order to evoke a response, both from the activation of mechanoreceptors on the skin and through bone-conducted acoustic stimulation. A first description of our system and our preliminary results showing reduction in apneas duration and desaturations were described in [2]. In [1], we studied 24 patients from 5 centers, compared to 8 patients in a single center in the work by Waeber et al Our results in a larger population extended the knowledge by demonstrating that responses to stimulation therapy are clearly patient-specific, requiring to adapt stimulation intensity over time.…”

Kinesthetic stimulation for obstructive sleep apnea syndrome: An “on-off” proof of concept trial

“…Details of the PASITHEA kinesthetic stimulation system have been previously reported 20,22 . The study was conducted in accordance with applicable good clinical practice requirements in Europe, French law, ICH E6 recommendations, and the ethical principles of the Helsinki Declaration (1996 and 2000).…”

Kinesthetic stimulation for obstructive sleep apnea syndrome: an “on-off” proof of concept trial

“…We conducted a multicenter, proof-of-concept, open-label, prospective study comparing, within a single night, kinesthetic stimulation "on" or "off " periods at 5 hospital-based university centers in France (Grenoble, Montpellier, Angers, Tours and Rennes). Details of the PASITHEA kinesthetic stimulation system have been previously reported 20,22 . The study was conducted in accordance with applicable good clinical practice requirements in Europe, French law, ICH E6 recommendations, and the ethical principles of the Helsinki Declaration (1996 and 2000).…”