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

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

Study Overview

• Status: Recruiting
• Conditions: Mental Health
• Intervention / Treatment: Device: Neuphoria Wearable

Detailed Description

This remotely administered decentralized trial is designed to explore the efficacy of the Neuphoria neurofeedback device in enhancing cognitive performance and achieving peak mental states through advanced EEG technology. By monitoring brainwave activity in real-time, this trial aims to provide personalized feedback to participants, enabling them to train their brains for improved focus, creativity, and flow states. The device serves as a comprehensive brain optimization platform, offering personalized assessments, data-driven insights, and actionable recommendations for mental well-being.

In an era where mindfulness and meditation are highly valued, yet rarely quantified, this study collaborates with Neuphoria to venture into measuring higher states of consciousness, blending scientific rigor with the art of introspection. The objective is to transform beliefs and anecdotal evidence about consciousness and mental wellness into empirical data, thereby redefining our understanding of mental health.

Participants in this study are guided through an exploration of their mental landscapes, with the goal of capturing data that reflects their journey towards higher consciousness. Through engagement with meditation and mindfulness techniques, participants will be able to gain insights into their stress levels and mindfulness tendencies. These insights will be quantified through established tools such as the Perceived Stress Scale and the Freiburg Mindfulness Inventory, offering a structured pathway to personal mental wellness enhancement and elevated consciousness.

The primary aim of this trial is to objectively measure shifts in consciousness in participants using EEG data, in conjunction with traditional mindfulness and stress metrics. By providing personalized insights into how meditation and mindfulness practices affect mental health, the study empowers participants to make informed decisions about their self-care routines and investments in personal development.

The significance of this study lies in its potential to convert subjective experiences of meditation into objective, quantifiable data. This endeavor bridges the gap between belief and measurable outcomes, advancing our understanding of how mindfulness practices influence consciousness and mental health. While acknowledging the limitations in the universal applicability of the results, the personalized insights gleaned from this study promise to be invaluable for participants eager to deepen their mindfulness practice and achieve a state of equanimity. Through this remotely conducted trial, we aim not only to explore the boundaries of mental wellness but also to offer a scientifically grounded pathway for individuals seeking to optimize their mental states.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Amsden; Phone Number: 646-679-2479; Email: help@efforia.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Recruiting
      • Efforia
      • Contact: Matthew Amsden; Phone Number: (646) 679-2479; Email: help@efforia.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Can read and understand English.
• US resident.
• Willing and able to follow the requirements of the protocol.

Exclusion Criteria:

• Individuals with severe mental health disorders
• Individuals with low frustration tolerance
• Individuals without access to emergency medical care
• Individuals involved in regulated professions
• Individuals with skepticism towards digital monitoring
• Individuals without a support system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm where participants act as their own control	Device: Neuphoria Wearable; Neuphoria wearable measures Electroencephalography (EEG) brainwaves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline (Day 1-7) in cognitive profile metrics at 4 to 5 weeks after the start of the intervention
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.	Change from baseline (Day 1-3) in perceived stress levels at 4 to 5 weeks after the start of the intervention
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.	Change from baseline (Day 1-3) in mindfulness levels at 4 to 5 weeks after the start of the intervention
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.	Change from baseline (Day 1-7) in cognitive profile metrics at 4 to 5 weeks after the start of the intervention

Collaborators and Investigators

• Sponsor: Efforia, Inc

Publications and helpful links

Helpful Links

• Additional information and join instructions on Efforia

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2025
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 25, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: 45835 (National Medical Research Register)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No