Hormonal, Amino Acid, Neurotransmitter, GDV and Physiological Testing of the Lifewave Silent Nights

ABSTRACT

Objective: This was a pilot study of 5 healthy subjects who all wore the active patch aged 21 and above, to assess physiological changes of the sealed FDA-registered homeopathic Silent Nights patch made by the Lifewave Corporation. Procedure: Subjects were consented and then the first baseline neuro-transmitter, amino acid, and hormonal samples were collected for hormonal testing. Additional tests were done on days 2, 6, and 7. Gas Discharge Visualization device and Thought Technology ProCom with BioGraph Infinity and CardioPro software’s physiology suite and HRV testing were taken as a baseline and then days 2, 6, and 7 of the test week. The Telegen Absorption scale, Marlowe-Crowne Social Desirability scale, Profile of Mood States, Restorative Sleep Questionnaire, the Sleep Scale, Global Mode Scale and Hassles and Uplift scales, sVAS for sleep and a daily sleep and food diary were all utilized during the study. Participants: Participants were recruited by flyer and email. All participants were healthy, with no chronic conditions and over the age of 21. Results: Neurotransmitters, Amino Acids and Hormonal tests: Two of the participants showed a 202% increase in melatonin over the seven days. Serotonin was significant in all five subjects for all time points over seven days p=0.0030 on day 6 and p=0.0097 on day seven. Serotonin is the precursor necessary to make melatonin. Significant changes were detected for most neurotransmitter parameters for all time points. An exception to neurotransmitter significance was for Mtyramine (from day 1 to day 6 and day 7), Glutamate (from baseline to day 6), LDOPA (from day 1 to day 7), NAD/ADR (from day 1 to day 6), Normetane (from day 1 to Day 7), and Theanine (from day 1 to day 2, day 6, and day7), where no significant changes were observed. There were no significant differences detected for the changes from the baseline to the last treatment day assessment between arms for estradiol, progesterone, or testosterone. Physiological Measures: No significant changes from day 1 to day 2, 3, or 4 were detected for Average HRV/EMG parameters, except for Temperature (F) from Day 1 to Day 4 (epoch 1) (-8.5+/-4.43, p=0.0313) and Temperature (F) from Day 1 to Day 4 (epoch 2) (-8.82+/-5.45, p=0.0479). No significant changes from day 1 to day 2, 3, or 4 were detected for Mode HRV/EMG parameters, except for Temperature (F) from Day 1 to Day 4 (epoch 1) (-7.78+/-4.04, p=0.0313). No significant changes from day 1 to day 2, 3, or 4 were detected for Area HRV/EMG parameters, except for Temperature (F) from Day 1 to Day 4 (epoch 2) (-529.04+/-326.74, p=0.0479). GDV: A significant decrease in fractality dimension is observed (-0.04+/-0.03, P=0.0376) is observed from baseline to Day +6 at the “3 –Left” finger assessment. A marginally significant decrease was observed for the fractality form coefficient from baseline to Day +7 (-7.37+/-7.16, P=0.0828) at the “4 Right” finger assessment. Questionnaires: A significant decrease (-4.0+/-2.92, p=0.0373) in Global Mood Scale –Negative Affect from day 1 to day 5 was detected. Significant decreases in the POMS score from Day 1 to Day 6 (-9.2+/-4.02, p=0.0069) and from Day 1 to Day 7 (-12.6+/-2.61, P=0.0004) were observed. Marlowe-Crowne Scale showed that four of the five participants presented in the normal range for social correctness and desirability. One individual leaned toward politically correct answers. No significant changes were detected for both the Visual Analogue Scale for Sleep, the Hassle and Uplift scale, Telegen Absorption Scale, the Restorative Sleep Questionnaire and the Sleep Scale. Conclusion: The significant change in most of the neurotransmitters tested, in all participants, in a study with a sample size this small and with data taken for only a week is relevant. Rapid and consistent change in neurotransmitters to this degree over this period of time is unusual in the literature. Further, while there was no overall significance in Melatonin production in this trial because of the age differential of participants and small sample size, the 202% increase in melatonin in subjects who were under the age of 30 should be explored. It will be important to include age stratification, as Melatonin production is known to decline as one ages. The additional significance of the change in the temperature parameter in HRV recordings supports an over all down regulation of stress parameters which while not fully reflected in the data because of the small sample size, would reflect an overall down regulation of the stress parameters. Additional study should be done to determine if the significance of the temperature change in a larger sample size with a longer data taking period does in fact demonstrate a reduction in stress parameters. The GDV data supports the down regulation of stress parameters with significance in the areas of hypothalamus, nervous system and thoracic area of the polyvagal system. While there was no direct significance in the changes in the sleep questionnaires, the change in the Global Mood Scale and Profile of Mood States showed that there was a significant reduction in negative affect as a result of an increased feeling of wellbeing. Recommendations: A larger trial should be done to determine if the significance of neurotransmitter responses are consistent in a larger sample size and should be done over a longer period of time to determine if the longer period taking the data allows for the significant increase in serotonin in all subjects to create an increase in melatonin in all subjects as serotonin is the precursor to melatonin.

Study available

https://www.researchgate.net/publication/281494911_Hormonal_Amino_Acid_Neurotransmitter_GDV_and_Physiological_Testing_of_the_Lifewave_Silent_Nights_Patches