Sound Stops Stress Study: Evaluating the WAVwatch Effect

Sound Off Stress Study seeks to discover if WAVwatch 2.0-a sleek, wearable sound frequency device-can support mental harmony.

Study Overview

• Status: Recruiting
• Conditions: Stress
• Intervention / Treatment: Device: WAVWatch 2.0

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 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: Child; 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 skin sensitivities
• Individuals with auditory conditions
• Individuals with severe anxiety or mental health disorders
• Pregnancy
• Individuals prone to irritation or frustration

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: WAVWatch 2.0; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Change from baseline (Day 1-3) in depression, anxiety, and stress levels at 4 weeks after the start of the intervention (Day 27-33)

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): August 25, 2025
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): August 25, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Estimated): December 15, 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

• Other Study ID Numbers: 37459

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