StressNCT07281989
Sound Stops Stress Study: Evaluating the WAVwatch Effect
A study testing WAVWatch 2.0 in people with Stress, run by Efforia, Inc at 1 site in United States.
Trial summary
Sound Off Stress Study seeks to discover if WAVwatch 2.0-a sleek, wearable sound frequency device-can support mental harmony. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- WAVWatch 2.0
- 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 Aug 2025to 25 Aug 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, 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 skin sensitivities
- Individuals with auditory conditions
- Individuals with severe anxiety or mental health disorders
- Pregnancy
- Individuals prone to irritation or frustration
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
Sound Off Stress Study seeks to discover if WAVwatch 2.0-a sleek, wearable sound frequency device-can support mental harmony.
Read the detailed description
This remotely administered decentralized trial is designed to rigorously evaluate the efficacy of the WAVwatch 2.0, a cutting-edge sound frequency device, in mitigating stress and everyday anxiety. In an era where stress pervades our daily lives, the need for innovative, science-backed solutions has never been more critical. Amidst the growing social media enthusiasm surrounding sound therapy's tranquil effects, this study seeks to scientifically substantiate the capabilities of WAVwatch 2.0, aiming to either validate or debunk the widespread claims of its beneficial impact on mental states.
The primary objective is to equip participants with precise, data-driven insights regarding the potential of WAVwatch 2.0 to diminish stress and anxiety levels. By partaking in this investigation, individuals will gain a personal understanding of their mental wellness journey, assessing firsthand whether this sophisticated, wearable technology can integrate seamlessly into their lives and foster the tranquility and equilibrium they aspire to achieve.
The core aims and objectives of this trial center around the thorough assessment of WAVwatch 2.0's effectiveness in lowering stress and anxiety, whilst concurrently promoting overall life satisfaction. Through personalized feedback, participants will be endowed with the knowledge necessary to make enlightened decisions regarding their stress management strategies and potential financial commitments to wellness technologies.
The significance and impact of this study are vast, with the potential to transform the landscape of personal stress management. By delivering evidence-based insights into the efficacy of sound frequency technology in enhancing mental wellness, this research could pave the way for more informed, individualized choices in non-clinical anxiety relief methods. While WAVwatch 2.0 may not be universally applicable, its evaluation serves as a critical step towards diversifying and enriching the arsenal of tools available for achieving mental well-being, thus empowering participants to make well-informed decisions concerning their wellness journeys.
- Conditions
- Stress
- Being tested
- WAVWatch 2.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAVWatch 2.0Device
The WAVwatch 2.0, a wrist-worn device intervention, leverages 'calming' frequencies to reduce stress and non-clinically relevant anxiety, aligning with scientific evidence supporting sound therapy's potential.
| 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: WAVWatch 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (Day 1-3) in perceived stress levels at 4 weeks after the start of the intervention (Day 27-33)
General Anxiety Disorder (GAD-7)
The GAD-7 is a 7-item questionnaire used to assess the severity of generalized anxiety disorder (GAD) in adults. The score is based on the responses to seven questions about the frequency of common anxiety symptoms over the past two weeks.
Measured: Change from baseline (Day 1-3) in anxiety severity at 4 weeks after the start of the intervention (Day 27-33)
NIH Toolbox® Item Bank v3.0 - General Life Satisfaction (Ages 18+)
This is a survey aimed at assessing the general life satisfaction of individuals aged 18 and above. Participants are asked a series of questions to which they can respond by indicating their level of agreement or disagreement.
Measured: Change from baseline (Day 1-3) in general life satisfaction at 4 weeks after the start of the intervention (Day 27-33)
Depression, Anxiety and Stress Scales (DASS-21) Survey
The Depression, Anxiety, and Stress Scales (DASS-21) is a widely recognized psychological assessment tool designed to measure the severity of symptoms related to depression, anxiety, and stress. It consists of 21 questions that assess various emotional and psychological factors. Participants are asked to rate the frequency and intensity of their experiences over the past week. The DASS-21 survey provides a quick and reliable way for clinicians, researchers, and individuals to gauge their levels of depression, anxiety, and stress, making it a valuable instrument for mental health assessment and research.
Measured: Change from baseline (Day 1-3) in depression, anxiety, and stress levels at 4 weeks after the start of the intervention (Day 27-33)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start25 Aug 2025
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- NCT07281989
- Sponsor's protocol ID
- 37459
- 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
- Sound Stops Stress Study: Evaluating the WAVwatch Effect
- ClinicalTrials.gov ID
- NCT07281989
- Acronym / sponsor ID
- 37459
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Efforia, IncIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 15 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.
Sound Off Stress Study seeks to discover if WAVwatch 2.0-a sleek, wearable sound frequency device-can support mental harmony.
Detailed description
This remotely administered decentralized trial is designed to rigorously evaluate the efficacy of the WAVwatch 2.0, a cutting-edge sound frequency device, in mitigating stress and everyday anxiety. In an era where stress pervades our daily lives, the need for innovative, science-backed solutions has never been more critical. Amidst the growing social media enthusiasm surrounding sound therapy's tranquil effects, this study seeks to scientifically substantiate the capabilities of WAVwatch 2.0, aiming to either validate or debunk the widespread claims of its beneficial impact on mental states.
The primary objective is to equip participants with precise, data-driven insights regarding the potential of WAVwatch 2.0 to diminish stress and anxiety levels. By partaking in this investigation, individuals will gain a personal understanding of their mental wellness journey, assessing firsthand whether this sophisticated, wearable technology can integrate seamlessly into their lives and foster the tranquility and equilibrium they aspire to achieve.
The core aims and objectives of this trial center around the thorough assessment of WAVwatch 2.0's effectiveness in lowering stress and anxiety, whilst concurrently promoting overall life satisfaction. Through personalized feedback, participants will be endowed with the knowledge necessary to make enlightened decisions regarding their stress management strategies and potential financial commitments to wellness technologies.
The significance and impact of this study are vast, with the potential to transform the landscape of personal stress management. By delivering evidence-based insights into the efficacy of sound frequency technology in enhancing mental wellness, this research could pave the way for more informed, individualized choices in non-clinical anxiety relief methods. While WAVwatch 2.0 may not be universally applicable, its evaluation serves as a critical step towards diversifying and enriching the arsenal of tools available for achieving mental well-being, thus empowering participants to make well-informed decisions concerning their wellness journeys.
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: WAVWatch 2.0Single arm where participants act as their own control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, 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 (5 listed)
- Individuals with skin sensitivities
- Individuals with auditory conditions
- Individuals with severe anxiety or mental health disorders
- Pregnancy
- Individuals prone to irritation or frustration
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 |
|---|---|---|
| WAVWatch 2.0The WAVwatch 2.0, a wrist-worn device intervention, leverages 'calming' frequencies to reduce stress and non-clinically relevant anxiety, aligning with scientific evidence supporting sound therapy's potential. | Device | Single arm where participants act as their own control |
Primary outcome
Perceived Stress Scale (Past Week Version)
Time frame: Change from baseline (Day 1-3) in perceived stress levels at 4 weeks after the start of the intervention (Day 27-33)
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.
General Anxiety Disorder (GAD-7)
Time frame: Change from baseline (Day 1-3) in anxiety severity at 4 weeks after the start of the intervention (Day 27-33)
The GAD-7 is a 7-item questionnaire used to assess the severity of generalized anxiety disorder (GAD) in adults. The score is based on the responses to seven questions about the frequency of common anxiety symptoms over the past two weeks.
NIH Toolbox® Item Bank v3.0 - General Life Satisfaction (Ages 18+)
Time frame: Change from baseline (Day 1-3) in general life satisfaction at 4 weeks after the start of the intervention (Day 27-33)
This is a survey aimed at assessing the general life satisfaction of individuals aged 18 and above. Participants are asked a series of questions to which they can respond by indicating their level of agreement or disagreement.
Depression, Anxiety and Stress Scales (DASS-21) Survey
Time frame: Change from baseline (Day 1-3) in depression, anxiety, and stress levels at 4 weeks after the start of the intervention (Day 27-33)
The Depression, Anxiety, and Stress Scales (DASS-21) is a widely recognized psychological assessment tool designed to measure the severity of symptoms related to depression, anxiety, and stress. It consists of 21 questions that assess various emotional and psychological factors. Participants are asked to rate the frequency and intensity of their experiences over the past week. The DASS-21 survey provides a quick and reliable way for clinicians, researchers, and individuals to gauge their levels of depression, anxiety, and stress, making it a valuable instrument for mental health assessment and research.
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.
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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 WAVWatch 2.0 in people with Stress, 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 5 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?
Perceived Stress Scale (Past Week Version) (time frame: Change from baseline (Day 1-3) in perceived stress levels at 4 weeks after the start of the intervention (Day 27-33)). 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.