RESUMO
OBJECTIVE: To study the effectiveness and safety of the sleep normalization medical device SONYA in the treatment of insomnia. MATERIAL AND METHODS: The effectiveness and safety of the SONYA device was studied in 32 subjects randomized into two groups - those who received stimulation using this device and those who received false stimulation (placebo). The indicators of subjective sleep characteristics, polysomnography, and emotional state were evaluated. RESULTS: The SONYA device exerts the positive effect on the main characteristics of night sleep and the emotional state of patients. The overall sleep efficiency, the total duration of delta sleep in its 1st and 2nd cycles, the delta sleep index significantly increased, while the time of falling asleep and the time of onset of delta sleep as well as the number and duration of night awakenings decreased. The severity of emotional and motivational disorders significantly decreased in the form of a decrease in the level of state anxiety, an increase in the background mood, the level of cheerfulness and well-being. No adverse events and side-effects from the use of the SONYA device have been recorded. CONCLUSION: According to the results of clinical studies, the SONYA device was registered as a medical device of the 2nd safety class for the treatment of insomnia of inorganic nature (F51.0) and sleep-wake disorders of inorganic nature (F51.2).