Mental HealthNCT07298369
Cracking Consciousness Study With Monroe & Neuphoria (Cohort 2&3)
A study testing Neuphoria Wearable in people with Mental Health, run by Efforia, Inc at 1 site in United States.
Trial summary
In partnership with Monroe, this EEG neurofeedback study is looking at the efficacy of Neuphoria with Monroe for mental clarity and well-being. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Neuphoria Wearable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2025to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Efforia
New York, New York, 10003
Matthew Amsden, (646) 679-2479, help@efforia.com
About this study
In partnership with Monroe, this EEG neurofeedback study is looking at the efficacy of Neuphoria with Monroe for mental clarity and well-being.
Read the 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.
- Conditions
- Mental Health
- Being tested
- Neuphoria Wearable
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuphoria WearableDevice
Neuphoria wearable measures Electroencephalography (EEG) brainwaves.
| Study group | Role | What they receive |
|---|---|---|
| Single arm where participants act as their own control | Experimental | Single arm where participants act as their own control Receives: Device: Neuphoria Wearable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline (Day 1-7) in cognitive profile metrics at 4 to 5 weeks after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start25 Sep 2025
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Efforia, IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm observational where participants act as their own control
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efforia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298369
- Sponsor's protocol ID
- 45835
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cracking Consciousness Study With Monroe & Neuphoria (Cohort 2&3)
- ClinicalTrials.gov ID
- NCT07298369
- Acronym / sponsor ID
- 45835
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Efforia, IncIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In partnership with Monroe, this EEG neurofeedback study is looking at the efficacy of Neuphoria with Monroe for mental clarity and well-being.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm observational where participants act as their own control
| Arm | Type | Receives |
|---|---|---|
| Single arm where participants act as their own control | Experimental | Device: Neuphoria WearableSingle arm where participants act as their own control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuphoria WearableNeuphoria wearable measures Electroencephalography (EEG) brainwaves. | Device | Single arm where participants act as their own control |
Primary outcome
EEG Spectral Power by Frequency Band
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Additional information and join instructions on EfforiaLink provided by the sponsor.
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuphoria Wearable in people with Mental Health, run by Efforia, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Amsden (646-679-2479, help@efforia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG Spectral Power by Frequency Band (time frame: Change from baseline (Day 1-7) in cognitive profile metrics at 4 to 5 weeks after the start of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.