Sound Stops Stress Study: Evaluating the WAVwatch Effect

NCT07281989 | Recruiting FDA Device

• 1 other identifier: 37459
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

Single arm where participants act as their own control

EXPERIMENTAL

Single arm where participants act as their own control

Device: WAVWatch 2.0

Interventions

WAVWatch 2.0 DEVICE

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.

Single arm where participants act as their own control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), 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 skin sensitivities
• Individuals with auditory conditions
• Individuals with severe anxiety or mental health disorders
• Pregnancy
• Individuals prone to irritation or frustration

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

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 15, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)