A double-blind placebo-controlled heart rate variability investigation to evaluate the quantitative effects of the organic nanoscale aeon patch on the autonomic nervous system

In this first double-blind-placebo-controlled investigation of the Aeon Patch, electrocardiographic data were acquired from 50 well-hydrated volunteers [21 females and 29 males, age: 19-79, weight: 117 334 lbs, height: 5'–6',3''], under 3 different conditions for a total duration of 15 min (5 min/condition). Condition1: Control (C) while wearing no Patch, Condition 2: Placebo (P) or Active (A) after wearing either the Placebo or the Aeon Patch for 20 min, and Condition 3: Active (A) or Placebo (P) after wearing either the Aeon or the Placebo Patch for 20 min. There was a washout period of 15 min between Conditions 2 and 3. All involved in the investigation were blind to the (A) and (P) Patches as they looked exactly the same and were assigned in a random fashion. The hypothesis to be tested was: Wearing the Aeon Patch for 20 min reduces stress. Data were first quality assured and those subjects who showed a parasympathetic response after wearing the Patch within 20 min were identified as early responders. Thirty subjects (60%) achieved a relaxed state after wearing the Aeon Patch as early as 20 min. Statistical analysis (one-sample inference) was used to compare the spectral features of the responders. The normalized LF/HF decreased significantly (24% ± 9% after 20 min) in condition (A) compared to condition (P) with a p-value < 0.047 (n = 30) in responders. Therefore, the hypothesis that wearing the Aeon Patch for 20 min reduces stress was accepted as true.