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

NCT07298369 | Recruiting FDA Device

• 1 other identifier: 45835
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mental Health

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Single arm where participants act as their own control

EXPERIMENTAL

Single arm where participants act as their own control

Device: Neuphoria Wearable

Interventions

Neuphoria Wearable DEVICE

Neuphoria wearable measures Electroencephalography (EEG) brainwaves.

Single arm where participants act as their own control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Efforia, Inc: lead

Study Sites (1)

Efforia

New York, New York, 10003, United States

RECRUITING

Related Links

• Additional information and join instructions on Efforia

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Matthew Amsden

CONTACT

646-679-2479; help@efforia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Arm observational where participants act as their own control

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 23, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)