Cracking Consciousness Study With Monroe & Neuphoria (Cohort 2&3)

Condition(s) studied

Investigational drug(s) / intervention(s)

Neuphoria Wearable: Neuphoria wearable measures Electroencephalography (EEG) brainwaves.

Study summary

In partnership with Monroe, this EEG neurofeedback study is looking at the efficacy of Neuphoria with Monroe for mental clarity and well-being.

Eligibility

Primary outcome measure(s)

• EEG Spectral Power by Frequency Band — Change from baseline (Day 1-7) in cognitive profile metrics at 4 to 5 weeks after the start of the intervention
  Electroencephalography (EEG) will be used to quantify spectral power across standard frequency bands (delta \[1-4 Hz\], theta \[4-8 Hz\], alpha \[8-12 Hz\], beta \[12-30 Hz\]). Power values will be derived using proprietary signal processing algorithms and summarized as relative power per band.
• Perceived Stress Scale (Past Week Version) — Change from baseline (Day 1-3) in perceived stress levels at 4 to 5 weeks after the start of the intervention
  The Perceived Stress Scale (Past Week Version) is a modified version of the classic stress assessment tool that evaluates stress levels based on recent experiences within the last week. This scale helps in understanding how various situations have recently affected an individual's feelings and perceived stress levels. By focusing on a shorter time frame, it provides a more immediate assessment of stress, which can be particularly useful for quickly evaluating the effectiveness of stress management strategies or interventions. The tool retains its original structure, ensuring its reliability while making it more relevant for current stress evaluation. Score Range Minimum: 0 Maximum: 40 Interpretation Higher scores indicate worse outcomes, reflecting greater perceived stress over the past week.
• Freiburg Mindfulness Inventory — Change from baseline (Day 1-3) in mindfulness levels at 4 to 5 weeks after the start of the intervention
  The Freiburg Mindfulness Inventory (FMI) is a valid and reliable questionnaire designed to measure mindfulness. The 14 items in the inventory cover all aspects of mindfulness. Participants are asked to reflect on their experiences over a certain period of time and answer each statement as honestly and spontaneously as possible. There are no 'right' or 'wrong' answers, the focus is solely on personal experience. Score Range The range depends on the version used: 14-item version (FMI-14): Minimum: 14 Maximum: 56 Interpretation Higher scores indicate better outcomes, reflecting greater levels of mindfulness. Lower scores indicate lower mindfulness.
• EEG-Derived Cognitive State Index — Change from baseline (Day 1-7) in cognitive profile metrics at 4 to 5 weeks after the start of the intervention
  A composite cognitive state index derived from EEG spectral features, reflecting participant alertness and engagement. The index is calculated using a proprietary algorithm and reported on a normalized scale.

Trial sites (1)

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