Today, mental health assessments rely solely on patients reporting their symptoms which are by nature, subjective. Such subjectivity often impacts symptom reporting and therefore incorrect diagnosis and treatment.
Medibio’s technology will aid clinicians in the early detection of mental health conditions and empower individuals to screen and better understand their mental health.
Medibio’s technology focuses on screening for depressive symptoms – known as a depressive burden.
Data obtained from electroencephalographic (EEG) and electrocardiogram (ECG) recordings are processed through our proprietary algorithms in; sleep, nocturnal heart rate, and heart rate variability (HRV). The structural components of Medibio’s algorithms are developed based on Artificial Intelligence (AI). The algorithm development, build, and testing are supported by clinical pre-validation trials. These trials are followed by validation-to-commercialization trials performed with the highest FDA standards and according to the Agency regulations. Each clinical step of our validation process is consulted and presented to the FDA regulatory body for final approval.
HEART RATE VARIABILITY IS CRITICAL TO PHYSICAL, MENTAL & SLEEP HEALTH
The determination of depressive burden is achieved by combining objective biomarkers of sleep macro and microstructures to heart rate and heart rate variability, to map autonomic modulation throughout sleep staging. The autonomic modulation is one of Medibio’s proprietary and novel technological features.
THE HRV CONNECTION
HRV is a sensitive measure of sleep deprivation and highly correlates with psychomotor performance measured with the Psychomotor Vigilance Test (PVT).
High sleep onset latency (the time it takes one to fall asleep) and poor sleep quality are associated with a higher heart rate and lower HRV.
Chronic insomnia and sleep deprivation can also affect HRV.
In depression, the HRV analysis demonstrates a predominant sympathetic modulation and a parasympathetic withdrawal.
Obstructive Sleep Apnea (OSA) is associated with lower HRV. This reduction can be worsened if they have another comorbid condition that affects their HRV, such as metabolic syndrome.
HRV has been suggested as a marker for obstructive sleep apnea and as a surrogate of intervention (CPAP treatment) by partially reversing the effects of sleep apnea on HRV.
Heart rate and HRV should be added as ancillary clinical information during Multiple Sleep Latency Tests (MSLT).
In circadian sleep disturbances, cardiac measures during sleep loss give a new window that may allow a complete understanding of the interaction of sleep and arousal systems as controllers of performance and alertness.
Mapping autonomic function, HRV, throughout the four sleep stages will add a new dimension in sleep architecture features that will better inform researchers of autonomic dysregulation associated with sleep disturbances and potential comorbid mental health conditions without the requirement of additional screens and assessments.
STAGER is a software-only medical device that analyses Electroencephalogram (EEG) and Electrocardiogram (ECG) data collected during polysomnography to verify sleep stages and heart rate variability (HRV) in patients suffering from primary or secondary sleep disturbances. STAGER uses artificial intelligence, machine learning and deep learning methods of algorithm development to analyse large amounts of raw data, including autonomic nervous system modulation throughout sleep stages, to highlight key information to assist the physician in understanding the patient’s condition.
Currently, the gold standard for identifying sleep stages in a sleep laboratory setting is a 60 to 90-minute visual assessment conducted by sleep technicians. STAGER performs the same assessment in 60 to 90 seconds, thereby providing improved efficacy for overall patient evaluation by sleep medicine technicians, under the supervision of a physician.