Science Behind Technology

Phototherapy Induced Metabolism Change Produced by the LifeWave X39 Non-transdermal Patch

International Journal of Research Studies in Medical and Health Sciences Volume 6, Issue 5, 2021

Purpose: To determine X-39 patch impact in stimulation of Copper peptide biosynthesis and bio-available amino acid levels, neurotransmitters production, memory, sleep quality, vitality, muscle relaxation and blood pressure.

Summary: The results of the double blind randomized controlled trial of 50 subjects using the LifeWave non-transdermal X-39 phototherapy patch produced an increase in 8 amino acids at significant levels. The study showed there was an improvement in short term memory at significant levels over 7 days, in quality of sleep at significant levels within 24 hours and a self-reported increase in vitality at near significant levels in 7 days. The findings suggest this patch is not only stimulating the biosynthesis of copper-peptide production, but also increases neurotransmitters production and improves metabolism.

• — Melinda H. Connor, DD, PhD, AMP, FAM
• — Caitlin A. Connor, MAcOM, DAOM
• — Naran Gombusuren, PhD
• — Jens Eickhoff, PhD
• — Nathan Anderson, MACOM, LAc
• — Marsha Perry, RN, MA
• — Leonard Peugh, MAcOM

 Study Report #1: Clark D. LifeWave Energy Patches Infrared Study. Dec 12, 2005. Safety issues: • No adverse events were reported. Patch instructions and study procedures: • In this study, abnormal asymmetric infrared measurements were observed in each case which warranted discussion and consideration of patch placement. Our initial interest was the concept that by placing patches on abnormal thermal regions, it would allow us the ability to control abnormal physiological conditions, which in turn, would change the energies of the individual. • The primary aim of this study was to demonstrate a physiological thermal response to the Energy Enhancer® patches within a five minute period. • 36 healthy subjects were enrolled, between 22 to 72 years of age. • A subset five subjects from the sample, was given placebo patches. • Infrared Imaging Measurements were performed with a highly sophisticated Computerized Thermal Imaging Processing Camera “TIP”). The use of infrared imaging is a unique, non-invasive diagnostic imaging procedure which detects and records surface skin temperatures by measuring the variations in heat that is spontaneously emitted from body surfaces. This specific imaging accomplishes this by scanning the subject with a highly sensitive infrared camera that can measure thermal differences to a one-hundredth of a degree. The surface skin temperatures are affected by physiological responses of the individual. Specifically, the autonomic nervous system of the body controls the thermal response. The external skin temperature creates a “thermal map” that is an objective measure of normal as well as abnormal physiologic function. The infrared evaluation as a diagnostic procedure in evaluating normal physiologic function is an accurate and objective evaluation. • The Computerized Thermal Imaging Infrared Camera “TIP” was used to measure the 8-12 nanometer range of infrared output of the human body. This is the common range of infrared output by the body. The camera selected is the most detailed, focused and expensive on the current market. It also has proprietary software to capture, store and record the measured Infrared output of the body and record the data in a digital medium. Efficacy of patches in this study: • The response to the body by placing the patches in a region of hyperthermic state as measured by the infrared imaging proved a cooling response to the skin temperature readings both locally and distal from the site of application. This is a valuable corollary when understanding the measured response of the patches is proof that the patches emit some form of energy to the body to cause a hyperthermic region to cool. This can only be explained by the patches emitting a form of energy that influenced the autonomic nervous system via the subcutaneous vascular beds. • "The average thermal temperature pre patch is 32.239°C. The average thermal temperature post patch is 30.756 °C. The average Delta T is 1.483°C. Since the p (probability) value of .00001 in this study is greater than p value < 0.05 this indicates that the thermal temperature changes that occur when Energy Enhancer® patches are used are statistically significant." 

 Study Report #1: Clark D. LifeWave IceWave Infrared Study Aug 29, 2006. Safety issues: • No adverse reactions were reported. Patch instructions and study procedures: • “Infrared studies were completed on 30 people with active IceWave patches. The infrared data shows that the IceWave patches consistently create an overall nervous system response to generally cool a (hot) hyperthermic region when measured with precise infrared technology. Conversely, when a region is hypothermic (cold) the IceWave patches will have the opposite effect on the area, and influence by warming the localized region." • Acupoints used: - Patches were placed using the Cross Method (see Appendix). • The Computerized Thermal Imaging Processing Camera (“TIP”) was used to measure the 8-12 nanometer range of infrared output of the human body. This is the most common range of infrared output by the body. The use of infrared imaging is a unique, non-invasive diagnostic imaging procedure which detects and records surface skin temperatures by measuring the variations in heat that is spontaneously emitted from body surfaces. This specific imaging accomplishes this by scanning the subject with a highly sensitive infrared camera that can measure thermal differences to a one-hundredth of a degree. The surface skin temperatures are affected by the individual’s physiological responses. Specifically, the autonomic nervous system of the body controls the thermal response. The external skin temperature creates a “thermal map” that is an objective measure of normal as well as abnormal physiologic function. The infrared evaluation, as a diagnostic procedure in evaluating normal physiologic function, is an accurate and objective evaluation. It is a pure measure of a persons’ health without causing any harm to the patient which is required in this application. • After the calibration period, baseline infrared images were collected and reviewed to identify hyperthermic/hypothermic regions. Patches were then applied over specific hyperthermic regions and then after an interval of five to twenty minutes after the application of the patches, the infrared imaging measurements were performed again. Computerized thermal measurements were performed over the patch site before and after the five to twenty minute period and the thermal differences recorded. Efficacy of patches in this study: • “Infrared Imaging clearly shows that LifeWave IceWave patches provide a thermoregulating effect to the body causing the nervous system to respond by normalizing the anomalous region of the body. Symptomatic changes seen with the IceWave patches in my study included such things as pain relief, improved range of motion, changes in stiff joints, and reports of energy improvement." • "The study design was to first obtain a baseline measurement without patches and then to place the IceWave patches on the body over an identified hyperthermic area and measure the immediate response after five to twenty minutes. The body’s response after placing the patches 

 in a hyperthermic region, as measured by the infrared imaging, proved a cooling response to the skin temperature readings both locally and distal from the site of application." • "Thermal changes were seen in all 30 subjects. The average thermal temperature pre patch is 31.94°C. The average thermal temperature post patch is 30.85 °C. The average Delta T is 1.09°C. The minimum Delta T is 0.15°C. The maximum Delta T is 8.20°C. Using a student t-test, a p value of 0.008 is obtained. Since the p (probability) value of .008 in this study is a p value < 0.05 this indicates that the thermal temperature changes when IceWave patches are used are statistically significant." • An example of an infrared image from the clinical trial is shown below in Figure 2. • Figure 2: (Top) Infrared Images taken before the LifeWave pain relieving devices were applied to the participant. (Bottom) Infrared Images taken 5 minutes after the LifeWave devices were applied. It can be seen that LifeWave caused the hot inflamed areas (red color) to cool (green color). Assessment: This infrared study demonstrated both local and whole body effects occur as demonstrated by thermal changes both locally and distal to the site of application of the patches. The IceWave® Infrared Study performed on August 29, 2006 also showed that pain relief, improved range of motion, changes in stiff joints, and energy improvement also occurred. This study also showed that reduction in temperature and inflammation was noticeable within 5- 20 minutes demonstrating rapid pain relief. Study Report #2: DeRock JL, Clark D, Nazeran H. Infrared Thermal Imaging Quantifies the Efficacy of IceWave Patches in Musculoskeletal Pain Relief in Horses. Published in Journal of the American Holistic Veterinary Medical Association (Vol. 30, No. 1, 2011). Safety issues: • No adverse events were reported. Patch instructions and study procedures:  

 Study Report #1: Shealy N. TREATMENT OF INSOMNIA WITH NONTRANSDERMAL ACUPUNCTURE POINT ACTIVATION (A Pilot study). January 5, 2011. Safety issues: • No adverse events were reported. Patch instructions and study procedures: • In this open label pilot study, 25 subjects used Silent Nights® patches at night for 30 days. • These subjects had a range of self-assessed sleep difficulties and they measured changes in sleep over a 30 day period with sleep scales and questionnaires. Subjects wore the patches 5 days per week. • Individuals were instructed to place one of the patches on 1 of 5 specific acupuncture points at bedtime. • The acupoints tested were: A. Right Liver 3 B. Right Triple Heater 23 C. Right Triple Heater 17 D. Governing Vessel 24.5 or E. Right Stomach 36 • If individuals did not sleep adequately, on the next night they would move the Silent Nights® patch to another one of these acupuncture points until they found a placement that achieved the best possible sleep. Once they found an acupuncture point that worked for them then they would continue using the patch on that particular point on successive nights. • Validated sleep scales and questionnaires were used and recorded as baseline prior to patch wearing and then at the end of the study period. Efficacy of patches in this study: • In this study, 72% percent of the individuals had normal daytime sleepiness on the Epworth Sleepiness Scale (ESS Test). • At the end of the study, 80% noted improved quality of sleep on the Leeds Sleep Evaluation Questionnaire (LESQ Test). • Also, 88% of participants had improved length of sleep on the Pittsburgh Sleep Quality Index (PSQ Test). • Considering the safety and results obtained in this study of Silent Nights® patches, it is reasonable to suggest that they may well be one of the preferred potential approaches to insomnia since 72 to 88% of the subjects experienced significant improvement in sleep. Assessment: This study used three standard scales and questionnaires used in sleep studies. 

. Study Report #2: Blake-Greenberg S, Nazeran H. Silent Nights® Patch Improves Qualitative and Quantitative Measures of Sleep and Enhances Quantitative Makers of Organ Function. Presented at 22nd International Conference on Electronics Communications & Computing. Feb-Mar 2012. Safety issues: • No adverse events were reported. Patch instructions and study procedures: • Acupoint tested: 1. Triple Burner 23 2. Kidney 3 • Actigraphic measurements depicting movement during sleep, Electro Interstitial Scans (EIS) of different organs reflecting physiological functional status, Leeds Sleep Evaluation Questionnaire, as well as, sleep diary data reflecting subjective self-evaluation of sleep were collected from 20 volunteers [5 males and 15 females, 20-79 years of age) over a period of 3 weeks at baseline and at the end of each week afterwards. • Organs tested were: frontal and temporal lobes, hippocampus, hypothalamus, pituitary, thyroid, kidneys, adrenals, liver, small and large intestines. • Baseline data were acquired from all subjects at the beginning of the study period before wearing the Silent Nights® Patch. After one week of accommodation to wearing the Actiwatches, Silent Nights® Patch was worn nightly on the right temple 1 hour before sleep for 2 weeks. Efficacy of patches in this study: • Actigraphic data analysis demonstrated that compared to baseline on average there was 29% reduction in activity level during sleep, 22% reduction in total awake time, 28% increase in ratio of time in bed over awake time, and 28% reduction in restlessness after wearing the Silent Nights® Patch for 2 weeks. • The Leeds Sleep Evaluation Questionnaire and sleep diary data on average showed considerable qualitative improvements at the end of the study period in a number of sleep attributes such as: easier and quicker than usual getting to sleep, calmer with less wakeful periods than usual during sleep (better sleep quality), easier and requiring less time to waking up than usual in the mornings, feeling more alert than usual, and less disrupted balance and coordination upon awakening. • Statistical analysis of the EIS data revealed that there was significant improvement in cellular physiologic functional status of the brain (frontal lobe, temporal lobe, hippocampus, hypothalamus), cardiac ventricles, adrenals, and thyroid gland at the end of the study period with respect to the corresponding baseline data. Assessment: In summary, the overall data in this study demonstrated that the Silent Nights® Patch worn on the right temple (Triple Warmer 22) and right ankle (Liver 3) nightly one (1) hour before sleep for 2 weeks produced considerable improvements in the objective and subjective measures of sleep and caused an impressive improvement in the physiologic functional status of different parts of the brain and adrenal glands with significant enhancement on the functioning of the cardiac ventricles and thyroid glands. These two studies are supportive of the claim that the Silent Nights® patches improve sleep. 

 Study Report #1: Connor MH, Maret K. Gas Discharge Visualization Testing of LifeWave Glutathione Patches. Presented at 21st Annual ISSSEEM Conference June 24, 2011 Safety issues: • No adverse events were reported. Patch instructions and study procedures: • The focus of this study was to discover if there are specific physiological changes produced by the application of the Y-age Glutathione. • Additional interest was in whether there would be changes in the levels of focus of individuals participating which would be consistent with changes in glutathione production in relation to dopamine and if there would be changes consistent with recognized anti-oxidant effects on the liver, kidney, and nervous system including the spine. • This was a double-blind, placebo-controlled, randomized, pilot study of 10 active and 10 control healthy subjects aged 30 and above using the LifeWave Glutathione patch. • Subjects were tested using Gas Discharge Visualization (GDV), which was developed as a way of photographing and measuring the spectrum of gas emission from the fingertips and the potential biophoton emission. • Focus was assessed by the Visual Analogue for Focus (fVAS). • Acupoints tested: A. Conception Vessel 6 (CV 6) Efficacy of patches in this study: • For the control subjects, there was thus no difference shown in GDV between the initial and final runs using the placebo patches while there were significant changes after one hour of wearing the glutathione patches. These changes are in keeping with known effects of glutathione on the liver and kidneys supporting known antioxidant effects. • The p<.006 findings of impact on solar plexus region and specifically on the liver, kidney, and nervous system suggest that there may be a physiological effect of the LifeWave Glutathione patch consistent with recognized clinical effects of glutathione when placed at the CV6 acupuncture point. • Further, using the GDV software analysis program, the active group showed clear changes in the oscillation patterns of gas emission over a period of one hour, these findings are consistent with the non-linear dynamical theory of homeopathic remedies presented by Bell et al (2004, 2006, 2009). Control group in contrast shows normalizing consistent with previous GDV studies of healthy individuals. • These changes are in keeping with known effects of glutathione on the liver and kidneys supporting known antioxidant effects. • Subject self-assessment using the Visual Analogue for Focus (fVAS) showed improvement in cognitive focus in both groups with an average of 16% change in the active group and 19% change in the control group. fVAS data on the changes in focus levels are supported by matched pattern of change of the nervous system in the GDV data on the active group but not to a level of significance as the change was distributed across the body and not located in a single a case.