In clinical trials conducted at the KRISS (Korea Research Institute of Standards and Science) and Kyunghee University Hospital in 2019 and 2020, the effectiveness of treatment was demonstrated through analysis on EEG (electroencephalogram), ECG (electrocardiogram), melatonin (hormone) and Insomnia Severity Index (ISI).
In clinical trials conducted at the KRISS in South Korea in 2019, we demonstrated the parasympathetic activation effects of the ANS (autonomic nervous system) by analyzing ECG (Electrocardiogram).
Scientific Evidence
The VNS technology applied to amofit S was developed based on thousands of peer-reviewed papers, and its effectiveness was proven in the actual clinical trials. In a placebo-controlled study conducted at the KRISS, amofit S increased activities of the parasympathetic nervous system by up to 187%.
The result of analysis of ECG to evaluate the stress relaxation effects of AMO+ products are as follows:
1) There were significant changes in HF ratio on ECG after use of AMO+ for a short term (2 hours). It is thought that the parasympathetic nervous system is activated by wearing the product in the experiment. It is considered that AMO+ induces relaxation and sleep because parasympathetic activation dilates blood vessels and relaxes the mind and body.
2) However, there was no significant difference in HF ratio on ECG after use of the placebo product for a short term (2 hours).
3) There were significant changes in HF ratio on ECG after use of AMO+ for a long term (72 hours). This demonstrated that AMO+ not only has short term effects, but also provides long term effects, activating the parasympathetic nervous system.
4) The effect of activating the parasympathetic nervous system of AMO+ is considered effective for sympathetic hyperactivity (immune depression, increased fatigue, insomnia, etc.) suffered by many modern people due to heavy work load and stress.
In a clinical trial conducted at Kyung Hee University Hospital in 2019, the sleep improvement effect was demonstrated through analysis on Insomnia Severity Index (ISI).
We conducted a 30-day study with adults who self-reported sleep difficulties and after using AMO+, we found that: 95% of participants improved their overall Sleep Score; 85% were more satisfied with their sleep pattern; 75% reported positive impact on their daily functioning. A statistically significant reduction in mean Insomnia Severity Index (ISI) score from 15.7 (moderate insomnia) at baseline to 8.15 (sub-threshold insomnia) after 14 days of cVES treatment was observed. ISI score reduced by 7.55 (i.e., 48% reduction).
In a clinical trial conducted at the KRISS (Korea Research Institute of Standards and Science) in 2020, EEG (electroencephalogram), ECG (electrocardiogram) and melatonin (sleep-inducing hormone) were analyzed to demonstrate the effectiveness on the activation of parasympathetic nervous system of the ANS (autonomic nervous system) and the improvement in sleep, stress, anxiety, and brain function.
The HF ratio increased in both normal individuals and insomnia patients, indicating stress reduction. In the electroencephalogram (EEG) analysis, the increase of alpha wave ratios in F3, F4, Fp1, and Fp2 positions in insomnia patients after wearing real devices indicates stress reduction. In the saliva test, the increase in melatonin levels in insomnia patients at nighttime indicates an increase in sleep-inducing effects. In conclusion the real AMO+ devices reduce stress and improve sleep induction.
