30 Day
Evaluating the WAVwatch 2.0 for Better Sleep
| STUDY TITLE | Evaluating the WAVwatch 2.0 for Better Sleep |
|---|---|
| Submitted under umbrella | |
| Date submitted |
Apr 6, 2025 |
| End date |
There is no pre-specified end date and sub-studies remain open long-term. |
| Language |
English |
| Efforia AI IRB approval recommendation | |
| Recruitment page preview | |
| Author edit | |
| Informed consent | |
| Study author |
Linda Bamber, Joseph Bamber, John Bamber, Matthew Amsden |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
We all want to improve and optimize our sleep. Easier said than done, particularly if a natural and non-chemical treatment is preferred. The WAVwatch is a non-interventional wrist device that includes a special sound wave settings designed to induce and improve sleep. Join this study to explore how this device helps you improve and optimizes your sleep without the grogginess that comes with even the most natural herbal & dietary supplements. |
| Participant engagement length |
30 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$597 |
| Included products & services |
WAVwatch 2.0 – Graphite: $697
|
| Outcome measures |
PROMIS Sleep Disturbance Scale Neuro-QOL Item Bank v1.0 –Fatigue – Short Form PROMIS Item Bank v.1.0 – Sleep-Related Impairment Survey |
| Methodology |
Single Arm longitudinal where participants act as their own control |
| Basic or advanced dissemination plan |
Basic |
| Deviation from recruitment approach |
No |
| Deviation from statistical approach |
No |
| Will study include “more about you questions” |
No |
| Clinicaltrials.Gov |
Yes |
| Committment to list findings on clinicaltrials.Gov |
Yes |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Why I created this study:
In today's fast-paced world, sleep quality is often compromised, leading to numerous health issues. One of the few things everyone agrees on is that a healthy sleep habit is imperative. But, what are the options if you want to avoid pharmaceuticals or even herbal supplements that may have side effects.? The WAVwatch 2.0, a cutting-edge soundwave device, has a remarkable number of users who claim to use the device to improve their sleep. This study bridges the gap between the strong anecdotal evidence and real clinical evidence. It's crucial to scientifically assess this tool's effectiveness to provide credible guidance for individuals seeking better sleep - and help you understand whether the device is actually improving your sleep.
My Objective for You:
Our objective is to empower you with the tools and knowledge needed to enhance your sleep quality. By participating in this study, you will engage with the WAVwatch 2.0 device, assessing its impact on your sleep through weekly PROMIS evaluations. Together, we'll uncover the potential of frequency therapy in transforming your sleep experience and overall well-being.
Aims & Objectives:
This study aims to evaluate the effectiveness of the WAVwatch 2.0 device in enhancing sleep quality among participants over a 30-day period. Objectives include measuring changes in sleep disturbance, fatigue, and sleep-related impairment using validated PROMIS and Neuro-QOL scales.
Significance & Impact:
This study is significant in potentially validating a non-invasive, accessible tool for improving sleep quality. Expected outcomes include improved sleep metrics and reduced fatigue, with limitations being individual variability and device compliance. The impact could revolutionize personal sleep management, offering a scientifically supported method to those struggling with sleep disturbances.
The Intervention
Included Products & Services
Product Name: WAVwatch 2.0 – Graphite
Quantity included: 1
Price: $697.00
Product Description: Everything in the universe (and your body) vibrates at a unique frequency. Research also suggests that action of nerves is based on sound pulses. Sound frequencies may help restore harmony through gentle, non-invasive energy. WAVwatch 2.0 can be used for Soreness Better Sleep Energy Relaxation Detox Weight Management Mental Clarity Emotions Stress Swollen Joints WAVwatch makes self-care effortless—just wear it and let the frequencies play!
Product Image:
Ingredients: Internal Use Only
Product Safety:
**Product Title:** WAVwatch 2.0 – Graphite Edition
**Product Description:**
Introducing the WAVwatch 2.0 – Graphite Edition, a revolutionary wearable device designed to harness the power of sound frequencies to promote wellness and enhance your quality of life. Drawing on the fascinating concept that everything in the universe, including the human body, vibrates at unique frequencies, WAVwatch 2.0 offers a holistic approach to health and wellbeing.
**Key Features:**
- **Holistic Health Tool:** Utilizes sound frequencies to help restore the body's natural harmony, influenced by ongoing research into the bioacoustic impact of nerve actions.
- **Versatile Applications:** Designed to assist with a range of physical and mental conditions including soreness, sleep disturbances, energy levels, relaxation, detoxification, weight management, mental clarity, emotional balance, stress reduction, and swollen joints.
- **Non-Invasive Therapy:** Offers a gentle, non-invasive form of energy therapy that works by merely wearing the device, allowing the embedded technology to interact naturally with your body's frequencies.
- **User-Friendly Design:** The sleek, modern Graphite design is not only stylish but also comfortable and discreet enough to wear all day, every day.
- **Ease of Use:** With simplicity at its core, the WAVwatch 2.0 requires no complex setup or maintenance. Simply put it on and let it work its magic.
**Benefits:**
- **Self-Care Simplified:** WAVwatch 2.0 makes maintaining daily wellness as easy as wearing a watch. It's designed for anyone seeking a natural boost to their body’s ability to heal and maintain balance.
- **Science-Backed Approach:** Inspired by cutting-edge research in the field of bioacoustics, the WAVwatch 2.0 taps into the natural science of sound frequencies to support your body's health.
- **Suitable for Everyone:** Whether you're an athlete looking to speed up recovery, a busy professional needing stress relief, or anyone in between, WAVwatch 2.0 is your partner in personal health and wellness.
Embrace the future of self-care and experience a new level of well-being with the WAVwatch 2.0 – Graphite Edition. Just wear it and let the frequencies play their part in your journey towards a healthier, more balanced life.
The WAVwatch sound frequency therapy device employs acoustic waves absorbed through the skin to promote wellness, with manufacturers and users reporting minimal safety risks. Below is a detailed safety and side effect profile based on available information:
Safety Profile
Design Safety
Non-invasive & drug-free: Uses low-wave acoustic frequencies absorbed through the skin and bones, avoiding synthetic electromagnetic fields or internet connectivity.
Water-resistant (not waterproof): Suitable for light exposure but not submersion.
No interference with medical devices: Reported compatible with pacemakers and grounding pads due to acoustic (not electrical) frequencies.
Precautions
Avoid during high-intensity activities or excessive sweating to prevent damage.
Adjust volume to levels 1–3 (or 4–8 per some guides) for safe absorption.
Not FDA-approved; labeled experimental and non-medical.
Contraindications
Known allergies to metals and plastics used in connected health devices.
Pregnancy: Consult a physician before use.
Metallic implants/prosthetics: Caution advised for sound therapy (specific to singing bowls in sources).
Sound-induced epilepsy: Potential risk with sound vibrations.
Reported Side Effects
Manufacturers and most users claim no adverse effects, even with incorrect frequency selection. However:
Minor discomfort: Rare reports of temporary tingling or warmth during use (implied in general sound therapy context).
Warranty & Damage Risks
Covers defects for 1 year; optional extended warranty for accidents, spills, or screen damage.
Excludes theft, loss, or shipping-related issues.
Key Considerations
Individual variability: Effectiveness and tolerance may vary; users are advised to test frequencies cautiously.
Hydration: Recommended to drink water during sessions to aid frequency absorption.
The WAVwatch is marketed as low-risk, but users should consult healthcare providers for specific medical conditions and adhere to usage guidelines.
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.
Below is a table identifying the kinds of people who should avoid being part of this trial:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Individuals with Severe Sleep Disorders | Participation without professional guidance | There may be underlying conditions that require medical intervention rather than experimental therapy. |
| People with Known Audio Sensitivity | Exposure to frequency therapy | The device emits sound frequencies that could exacerbate audio sensitivity issues. |
| Individuals with Chronic Gastrointestinal Issues | Risk of gastrointestinal symptoms | Although low, there's a theoretical risk that may not be suitable for individuals already dealing with such issues. |
| Those with Skin Allergies or Conditions | Potential skin reactions | Even with a very low likelihood, individuals with sensitive skin should exercise caution. |
| Persons Working in Sensitive Environments | Legal and professional conflicts | Users should verify the acceptability of using the device within their workplace or institutional guidelines. |
| Individuals with High Irritability or Anxiety | Risk of frustration or irritation | The device may cause discomfort or increased irritability in some individuals. |
| Pregnant or Nursing Individuals | Uncertain effects | The impact of frequency therapy on pregnancy or nursing is unknown and should be avoided without medical consultation. |
Study Design & Experience
Nightly Activity: Play the Sleep folder frequencies from the WAVwatch 2.0 device at bedtime.
Assesments and frequency:- Baseline: Complete the Baseline PROMIS Sleep Disturbance Scale, Baseline Neuro-QOL Fatigue Short Form, and Baseline PROMIS Sleep-Related Impairment Survey.
- Weekly: Complete the Weekly PROMIS Sleep Disturbance Scale, Weekly Neuro-QOL Fatigue Short Form, and Weekly PROMIS Sleep-Related Impairment Survey.
The study titled "Evaluating the WAVwatch 2.0 for Better Sleep" is designed to investigate the effects of the WAVwatch, a non-interventional wrist device, on improving sleep quality. This device employs specific sound wave settings purported to enhance sleep naturally, avoiding the side effects often associated with herbal and dietary supplements. This single-arm observational trial, referred to as a "Signal Phase" study at Efforia, will involve participants acting as their own control. Through this approach, researchers aim to gather preliminary evidence on the device's effectiveness in optimizing sleep patterns while also collecting crucial safety data that is currently lacking.
Participants in this study will engage in a 30-day trial, using the WAVwatch 2.0 to potentially improve their sleep quality. They will play the device's Sleep folder frequencies each night at bedtime, utilizing frequency therapy to enhance rest. Progress will be monitored through weekly evaluations using the PROMIS (Patient-Reported Outcomes Measurement Information System) tools, providing insights into sleep quality, disturbances, and related impairments. This study aims to scientifically substantiate the device's effectiveness, bridging the gap between academic research and popular beliefs, and equipping participants with knowledge to enhance their sleep and overall well-being.
Throughout the study, participants' data privacy and confidentiality will be carefully safeguarded, with all collected information securely stored and used exclusively for research purposes. The protocol schedule outlines a personalized plan, beginning with the activation of the WAVwatch sleep frequencies on the first night. Regular safety check-ins and assessments using the PROMIS Sleep Disturbance Scale, Neuro-QOL Fatigue Short Form, and Sleep-Related Impairment Survey will occur weekly. Should the results indicate a positive signal that the WAVwatch 2.0 is effective, more comprehensive study designs will be explored to validate these findings further. For detailed methodology and protocol information, refer to the "Minimal Risk Umbrella protocol.
Statistical Analysis Plan
Limitations & Justification
In conducting this single-arm observational trial under the Minimal Risk Citizen Science Umbrella Protocol, we acknowledge certain limitations inherent to the study design, particularly the absence of a control group. This lack of a comparative baseline may introduce bias, as it becomes challenging to discern whether observed changes are attributable to the WAVwatch 2.0 or other external factors. To mitigate this, we employ an expectations questionnaire, which allows us to quantify potential biases related to participant perceptions and expectations. By systematically assessing these biases, we aim to enhance the credibility of our findings and provide a clearer picture of the device's impact on sleep quality.
Moreover, the study design includes strategic measures to address additional limitations such as sample size and statistical validity. Despite being a single-arm trial, we ensure robust data interpretation through careful consideration of participant demographics and stratification, enhancing the reliability of our conclusions. The statistical methodology is designed to accommodate variability and potential confounders, thus offering a nuanced understanding of the WAVwatch 2.0's effectiveness. This trial primarily serves as a signal detection study, where any positive signals will justify subsequent, more comprehensive trials. Such an approach is crucial for determining the viability of the device as a non-invasive sleep management tool, laying the groundwork for future research that can more rigorously validate initial findings.
This study aligns with Efforia's mission to democratize clinical research by exploring questions and supporting researchers that might otherwise be overlooked. By operating under the Minimal Risk Umbrella Protocol, we not only maintain focus on participant safety and minimal risk but also provide a platform for innovative research into alternative therapies like frequency therapy. Our goal is to empower individuals by scientifically evaluating accessible, non-pharmaceutical interventions, thus potentially revolutionizing personal sleep management. For more detailed information on the protocol and its implications, individuals are encouraged to refer to the Minimal Risk Umbrella Protocol documentation.
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
The protocol for evaluating the WAVwatch 2.0 for Better Sleep appears to be suitable for the minimal risk umbrella protocol. The study focuses on a consumer health device, the WAVwatch 2.0, which does not require a prescription or physician diagnosis, aligning with the requirement for studies to examine legal, easily accessible interventions. Since the device is intended to improve sleep, a common aspect of general health and wellness, the study falls within the broad "health and wellness" domain. Furthermore, the study is designed to enhance productivity and wellness within normal ranges, rather than addressing any diagnosed disease state or regulated health condition, thereby conforming to the umbrella protocol's criteria.
Additionally, this study does not involve vulnerable populations, nor does it incorporate medical devices subject to regulatory approval, ensuring compliance with the criteria set out for minimal risk studies. The WAVwatch 2.0 is not classified as a medical device or pharmaceutical and is not subject to sports regulatory bans, making it a safe and suitable intervention for this umbrella protocol. The study design appears to be longitudinal, lasting several days, and does not include elements of blinding, deception, or require more than two blood draws. Overall, the protocol for evaluating the WAVwatch 2.0 for Better Sleep fits well within the established guidelines for minimal risk studies under this umbrella protocol.
Suitability for Pay to Participate Model
In considering the appropriateness of allowing participants to pay for the WAVwatch 2.0 in the "Evaluating the WAVwatch 2.0 for Better Sleep" study, several factors support this decision. The WAVwatch 2.0 is legally available on the open market in the United States, where consumers are generally willing to invest in innovative sleep aids, particularly non-chemical solutions that promise to enhance sleep quality. As sleep optimization is a priority for many, the cost of $597 is comparable to other high-quality sleep enhancement devices, such as smart sleep trackers or noise machines, which often fall within a similar or higher price range. The WAVwatch 2.0 provides added value beyond just convenience, as it offers a unique, non-invasive sound wave technology specifically designed to improve sleep, setting it apart from standard products available in the market.
Additionally, the typical target market for sleep improvement devices, primarily health-conscious individuals seeking non-invasive solutions, can generally afford the product without encountering financial hardship. We are told that WAVWatch sells almost 1,000 devices a month. While it is crucial to consider participant vulnerabilities, such as those experiencing severe sleep deprivation or related health issues, the transparent nature of the study and the provision of comprehensive information minimizes the risk of buyer's remorse. Participants are empowered to make informed decisions about their participation, thus aligning with Efforia's principles of respect for autonomy and informed consent. Furthermore, the study's design ensures that participants are not subjected to undue influence or exploitation, as they have the freedom to opt-in voluntarily, reflecting a fair and equitable research practice.
Human Subjects Protection Questionnaire
Beneficence
Is there a description, unambiguous research question, and purpose?
Yes, the study has a clear research question and purpose, which is to evaluate the effectiveness and safety of a product already available on the market. By focusing on individuals who have purchased the product, the study aims to gather real-world data on its usage and outcomes.Is the study built on what is known already?
Yes, the study leverages existing knowledge about the product, which has been used by consumers. It aims to add to this knowledge base by systematically collecting data on user experiences and outcomes, which will help refine understanding and guide future research.Will the study provide meaningful answers to the research question?
Yes, the study is designed to provide meaningful answers by collecting data directly from participants who have used the product, ensuring that the findings are relevant both to the individual participants and to the broader community interested in the product's effects.Will the study provide valid answers to the research question?
Yes, the study's design and methodology are structured to yield valid answers, as it incorporates participant feedback and real-world data collection, which enhances the reliability and validity of the results.
Non-maleficence
Are participants recruited with justifiable inclusion and exclusion criteria?
Yes, any individual who has already purchased the product is eligible to participate, which ensures that participants are familiar with the product and its usage. Efforia emphasizes participant responsibility to identify if the protocol is not right for them via clear risks and special considerations in the informed consent.Does the research team have the experience, skills, facilities, and time to complete the study?
Yes, the study is supported by the Efforia platform's extensive infrastructure, the real-life knowledge and experience of the study author, and oversight from Principal Investigator Matthew Amsden, who has extensive experience in decentralized trial innovation and management. Dr. Viral Patel is available to support and confirm any adverse events that may arise. Additional information is available in the Minimal Risk Umbrella Protocol.Is there a fair balance of benefits and harms (risks) for all with an interest in the study?
Yes, the study's unique approach provides added value to those who have purchased the product or service at no additional cost, while maintaining a low risk profile in line with the minimal risk protocol.Will participants receive appropriate care both during and after the study?
Yes, participants are advised to seek their own medical care in the case of an adverse event as per the informed consent. The minimal risk nature of the interventions and their availability on the open market means participation in the study provides more care than they would otherwise receive, particularly regarding adverse event monitoring.Is personal data handled appropriately (confidentiality)?
Yes, personal data is handled appropriately as per the guidelines detailed in the Minimal Risk Umbrella Protocol.
Autonomy
Have participants been offered a fair choice through the information they are given (presented in plain English) and consent process?
Yes, the informed consent document provides clear and comprehensive information about the study, including its risks, benefits, and the voluntary nature of participation, ensuring participants can make an informed decision.Has the research incorporated patient and participant views?
Yes, as Efforia is a citizen science clinical trial platform, this study is participant-driven and designed to include feedback from participants regarding their experiences with the treatment. The consent document encourages participants to ask questions and provide input throughout the study.
Justice
Are there fair payments for participation and financial recompense in case of harm?
Yes, while participants pay to participate, the study offers a valuable product and tracking of health outcomes, which provides intrinsic value. In case of adverse events, participants are instructed to seek medical care and report the incident to Efforia for further action, understanding that medical care is their own financial responsibility.Do participants have access to an independent complaints procedure (or advocate)?
Yes, participants can contact Efforia's support for any concerns or complaints, ensuring they have an independent avenue for addressing issues. If they prefer not to talk with someone at the approving IRB, there are independent ethics review board numbers included in the informed consent that they can contact.Will the project be registered and results reported in the public domain?
Yes, Efforia commits to transparency and makes personal results immediately available to participants. The authors are running these studies to build their own credibility via generalizable results.