Cracking Consciousness Study With Monroe & Neuphoria (Cohort 2&3)
ConditionMental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEfforia, Inc
About this trial
In partnership with Monroe, this EEG neurofeedback study is looking at the efficacy of Neuphoria with Monroe for mental clarity and well-being.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Can read and understand English.
US resident.
Willing and able to follow the requirements of the protocol.
Disqualifiers
Individuals with severe mental health disorders
Individuals with low frustration tolerance
Individuals without access to emergency medical care
Individuals involved in regulated professions
Trial design
Design model
Single group
Treatments tested in this trial
Neuphoria Wearable
DeviceNeuphoria wearable measures Electroencephalography (EEG) brainwaves.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Single arm where participants act as their own controlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
EEG Spectral Power by Frequency Band
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.
Time frame
Change from baseline (Day 1-7) in cognitive profile metrics at 4 to 5 weeks after the start of the intervention2
Perceived Stress Scale (Past Week Version)
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.
Time frame
Change from baseline (Day 1-3) in perceived stress levels at 4 to 5 weeks after the start of the intervention3
Freiburg Mindfulness Inventory
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.
Time frame
Change from baseline (Day 1-3) in mindfulness levels at 4 to 5 weeks after the start of the intervention4
EEG-Derived Cognitive State Index
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.
Time frame
Change from baseline (Day 1-7) in cognitive profile metrics at 4 to 5 weeks after the start of the interventionSponsors and contacts
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Source ClinicalTrials.gov