30 Day
Evaluating SleepWhale Drops for Rest & Resilience
| STUDY TITLE | Evaluating SleepWhale Drops for Rest & Resilience |
|---|---|
| Submitted under umbrella | |
| Date submitted |
Apr 21, 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 |
Hunter Kilburn, Weston McVicker, Matthew Amsden |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
Struggling with restless nights? Join our 30-day study evaluating SleepWhale Natural Sleep Drops (Extra Strength)—formulated to support deeper sleep and better days. We’re tracking weekly improvements in sleep quality, daytime performance, and resilience. Backed by science, powered by nature. Ready to feel the difference? Enroll now and be part of the SleepWhale discovery. |
| 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 |
$121 |
| Included products & services |
Sleepwhale Natural Sleep Drops (Extra Strength): $121
Sleepwhale Gift Card – $100.00: $100
|
| Outcome measures |
PROMIS Sleep Disturbance Scale Daytime Sleepiness Perception Scale (DSPS-4) Fatigue Perception and Impact Survey Resilience Assessment Scale |
| 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
Sleep issues are everywhere—racing thoughts, restless nights, and sluggish mornings are all too common. While many turn to synthetic or melatonin-based aids, more people are looking for natural solutions that support the body without grogginess or dependency. SleepWhale Natural Sleep Drops (Extra Strength) are a new, non-melatonin formulation made with adaptogens and botanicals to support calm, deep sleep.
The product is trending—but trend isn't truth. This study is here to gather real data on how SleepWhale actually works for you.
How This Study Works
Over 30 days, you’ll integrate SleepWhale into your nightly routine and complete weekly check-ins using scientifically validated self-report tools. You won’t need a sleep tracker or wearable device. That’s intentional.
Why? Because this study is focused on how you feel—not what your device thinks. Connected health devices can offer interesting data, but they often lack accuracy and rarely tell the full story. We care about the experience that matters most:
your own.
At the end of the study, if you have completed all the measurements in the study, as a token of our appreciation, you will receive not just detailed findings about how Sleepwhale worked for you, but also a $100 SleepWhale Gift card you can use for any future purchases with us.
Your Objective
Use SleepWhale Drops nightly for 30 days. Each week, as you respond to the validated self report measures, reflect on and report your sleep quality, fatigue, focus, and resilience. You’ll gain insight into your own sleep patterns—and contribute to a growing body of research around natural sleep support.
Study Aims & Objectives
To evaluate the impact of daily use of SleepWhale Natural Sleep Drops (Extra Strength) on self-reported sleep quality, disruption, daytime performance, and resilience over a 30-day period.
Why It Matters
SleepWhale is gaining real traction. That's great. But we feel you deserve real outcomes, not just hype and hope. While results may vary, this study is a step toward understanding how a non-melatonin solution like SleepWhale can support better sleep and better days—for you, and for the broader sleep community.
The Intervention
Included Products & Services
Product Name: Sleepwhale Natural Sleep Drops (Extra Strength)
Quantity included: 30
Price: $121.00
Product Description: The extra strength version of our melatonin alternative. Crafted with natural herbs and minerals that target the most critical parts of the sleep journey for your best next-day self.
Product Image:
Ingredients:
Serving size 1.0ml
Broad spectrum hemp extract: 25 mg
Broad spectrum hemp extract (CBN): 1.5 mg
Proprietary blend of Suntheanine (L-Theanine), GadoMag (Magnesium( Sibelius (Camomile) and M2 (Lion's Mane)
Product Safety:
Serving Size: 1.0 ml
Ingredients per Serving:
Broad Spectrum Hemp Extract (CBD): 25 mg
Broad Spectrum Hemp Extract (CBN): 1.5 mg
Proprietary Blend containing:
Suntheanine (L-Theanine)
GadoMag (Magnesium)
Sibelius (Chamomile extract)
M2 (Lion’s Mane mushroom)
Intended Use:
A natural sleep support supplement formulated to promote relaxation, reduce stress, and support restful sleep.
Ingredient Safety Overview:
CBD (Broad Spectrum Hemp Extract): Generally well-tolerated; promotes calm without intoxication. Avoid combining with strong sedatives or certain medications unless approved by a healthcare provider.
CBN: Known for mild sedative effects. Considered safe in low doses; not recommended during pregnancy or breastfeeding due to limited research.
L-Theanine (Suntheanine): Reduces stress and promotes mental calm. Non-sedating and non-habit forming.
Magnesium (GadoMag): Supports muscle and nervous system relaxation. Well-tolerated; high doses may cause digestive discomfort.
Chamomile (Sibelius): Traditionally used for sleep and relaxation. Safe for most, but those with ragweed allergies should consult a doctor.
Lion’s Mane (M2): Known for supporting cognition and mood balance. Rare instances of mild digestive upset have been reported.
Cautions:
Not recommended for individuals under 18.
Do not use if pregnant or breastfeeding without medical guidance.
May cause drowsiness; avoid driving or operating machinery after use.
Consult a healthcare provider before use if taking medications for sleep, anxiety, or depression.
Stick to the recommended serving size (1.0 ml per 24 hours), unless otherwise directed by a healthcare professional.
This product is not intended to diagnose, treat, cure, or prevent any disease.
Product Name: Sleepwhale Gift Card – $100.00
Quantity included: 1
Price: $100.00
Product Description: Experience a more restful night's sleep with our products. Scientifically designed to improve sleep quality, it utilizes proven techniques to help you fall asleep faster and wake up feeling refreshed. Say goodbye to restless nights and hello to a well-rested, revitalized you.
Product Image:
Ingredients:
Product Safety:
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.
Based on the risks and informed consent information provided, below is a table identifying the kinds of people who should avoid being part of this trial:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Individuals with Allergies | Known allergies to herbal or natural supplements | Risk of severe allergic reactions or interactions with existing allergies |
| Individuals on Medication | Currently taking medications that may interact with Sleepwhale | Potential for drug interactions leading to adverse effects or reduced efficacy of current medication |
| Individuals with Gastrointestinal Issues | Preexisting gastrointestinal conditions | Gastrointestinal symptoms may exacerbate existing conditions |
| Individuals with Skin Conditions | Existing dermatological conditions | Risk of skin and hair reactions may worsen existing conditions |
| Individuals Prone to Headaches | History of frequent or severe headaches | Moderate likelihood of headaches could exacerbate their condition |
| Individuals with Mental Health Conditions | Preexisting mental health disorders | Potential for mood changes or mental health discomfort to worsen existing conditions |
| Pregnant or Breastfeeding Individuals | Pregnancy or breastfeeding status | Lack of research on effects during pregnancy or breastfeeding, posing potential risks |
| Athletes and Competitive Participants | Subject to anti-doping regulations | Potential conflict with anti-doping rules and regulations |
| Individuals with Dependency Issues | History of dependence on sleep aids or other substances | Risk of developing dependency on Sleepwhale Natural Sleep Drops |
| Individuals with Dizziness or Fatigue Issues | Preexisting conditions related to dizziness or fatigue | Moderate likelihood of experiencing fatigue and dizziness could impact their daily functioning |
These individuals should consult with their healthcare provider to carefully consider their participation in the trial, given the potential risks and contraindications.
Study Design & Experience
Nightly: Take SleepWhale Natural Sleep Drops (Extra Strength) 15 minutes before bed, under the tongue for 1-2 minutes before swallowing.
Assesments and frequency:- Baseline: Complete the PROMIS Sleep Disturbance Scale, Daytime Sleepiness Perception Scale, Fatigue Perception Scale, and Resiliency Scale.
- Weekly: Complete the PROMIS Sleep Disturbance Scale, Daytime Sleepiness Perception Scale, Fatigue Perception Scale, and Resiliency Scale.
The study titled "Evaluating SleepWhale Drops for Rest & Resilience" is structured as a 30-day, single-arm observational trial where participants serve as their own controls. This design, referred to as a "Signal Phase" study at Efforia, seeks to gather preliminary evidence on the efficacy of SleepWhale Natural Sleep Drops (Extra Strength) in enhancing sleep quality, daytime performance, and resilience. By employing a method where participants act as their own control, the study aims to detect directional indications of positive outcomes attributed to the intervention, providing a foundation for possible future research with more rigorous study designs. The trial's outcomes will not only guide potential advancements in sleep support but will also yield crucial safety data, which is currently limited.
The study involves participants utilizing SleepWhale Drops nightly over a month-long period, with their experiences being documented through weekly check-ins. These check-ins employ validated self-assessment tools, including the PROMIS Sleep Disturbance Scale, Daytime Sleepiness Perception Scale, Fatigue Perception Scale, and Resiliency Scale. Unlike traditional sleep studies that rely on wearable technology, this study prioritizes subjective measures of sleep and well-being, emphasizing the participants' personal insights into their sleep quality and overall health. This approach underscores the importance of self-reported outcomes in understanding the real-world impact of SleepWhale Drops.
Participants embarking on this journey will receive a comprehensive experience that includes personalized insights, a $100 SleepWhale gift card upon study completion, and a comparative analysis of their sleep trends against other participants. Throughout the study, participants will be guided by baseline assessments and weekly feedback, enabling them to track their progress and understand their sleep needs better. The study experience is designed to integrate seamlessly into daily life, with practical tools like Google Calendar and Todoist ensuring that participants remain engaged and informed. Should this initial phase indicate a positive signal regarding the efficacy of SleepWhale Drops, it could pave the way for more detailed studies with enhanced design elements, as outlined in the Minimal Risk Umbrella protocol.
Statistical Analysis Plan
Limitations & Justification
The single-arm observational trial investigating SleepWhale Natural Sleep Drops presents several limitations inherent to its design, primarily the absence of a control group, which may introduce bias. Without a control group against which to compare results, distinguishing the true effect of the SleepWhale Drops from placebo effects or natural variations in sleep patterns is challenging. To address this, we have incorporated an expectations questionnaire, a strategic tool designed to quantify participants' biases and expectations. This approach allows us to understand how much of the observed changes can be attributed to participants' beliefs about the efficacy of the intervention, rather than the intervention itself. By examining these biases, we aim to provide a more nuanced interpretation of the data, acknowledging that participant expectations can significantly influence self-reported outcomes.
Despite the limitations of a single-arm design, the study employs a well-considered sample size and statistical methodologies to mitigate potential biases. The trial's design includes stratification by participant demographics, which enables a more detailed analysis of how different groups respond to the intervention. This stratification is crucial, given the variability in individual responses to sleep aids, which could otherwise obscure the true effects of the SleepWhale Drops. Furthermore, the study is structured as a signal detection trial, meaning its primary goal is to identify potential benefits that warrant further investigation. Should the results indicate a positive signal, this will pave the way for more rigorous, controlled studies that can validate findings with greater confidence. This phased approach ensures that the study remains robust and scientifically valuable despite its inherent design constraints.
The overarching aim of the Minimal Risk Citizen Science Umbrella Protocol, under which this study operates, is to democratize clinical research by supporting research questions and researchers that might otherwise be overlooked. By focusing on natural sleep solutions like SleepWhale Drops, this study aligns with Efforia's goal of expanding the scope of clinical research to include diverse, real-world interventions. This approach not only addresses the growing public interest in natural remedies but also enhances the inclusivity of clinical research by involving participants who are typically excluded from more traditional studies. To learn more about the strategies and methodologies employed to address these limitations, interested parties are encouraged to refer to the Minimal Risk Umbrella Protocol for additional insights.
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
The protocol, "Evaluating SleepWhale Drops for Rest & Resilience," appears to be suitable for inclusion under the minimal risk umbrella protocol based on the criteria provided. Firstly, the study seems to focus on a non-regulated dietary supplement, which falls within the "health and wellness" domain, as it aims to evaluate the effects of SleepWhale Drops on rest and resilience. This aligns with the criteria for exploring interventions that are generally recognized as safe (GRAS) and do not require a prescription or physician diagnosis. Additionally, the study does not involve any vulnerable populations and appears to be designed to enhance general health and wellness within normal ranges, further supporting its suitability.
Moreover, the design of the study likely involves minimal risk, as it examines a legal and readily accessible intervention without the need for regulatory approval. Assuming the study involves a longitudinal approach lasting several days and does not require more than two blood draws or any other invasive procedures, it should fit well within the minimal risk category. Additionally, it seems to avoid any elements that would classify it as unsuitable, such as the use of deception, targeting vulnerable populations, or requiring specific eligibility criteria beyond the general availability of the intervention. Therefore, based on the provided criteria, the protocol for evaluating SleepWhale Drops aligns with the requirements of the minimal risk umbrella protocol.
Suitability for Pay to Participate Model
In evaluating the appropriateness of allowing participants to pay for SleepWhale Natural Sleep Drops (Extra Strength) in the "Evaluating SleepWhale Drops for Rest & Resilience" study, it is essential to consider several key factors. Firstly, SleepWhale Natural Sleep Drops are legally available on the open market in the United States, suggesting that consumers are already familiar with and willing to purchase such products to improve sleep quality. Additionally, the price of $121 for the 30-day study appears to be in line with or potentially less than what consumers might pay for a month's supply of high-quality, natural sleep aids available in retail and online outlets, which often range in similar price brackets. The study provides added value beyond mere product purchase by offering participants structured tracking of their sleep quality improvements, daytime performance, and resilience, enhancing the perceived benefits of participation. In addition, the study concludes with a $100 SleepWhale gift card, bringing the price down to effectively $21 - a substantial discount.
Furthermore, the typical target market for SleepWhale Natural Sleep Drops likely includes health-conscious consumers who can afford such wellness investments without severe financial strain. It is important to note that the voluntary nature of participation, coupled with transparent information regarding costs and expected outcomes, supports participant autonomy and minimizes the risk of undue influence. The study's design and communication will need to ensure that potential participants are fully informed about the financial commitment and the nature of the product to prevent any significant buyer’s remorse. Overall, these considerations support the ethical justification for the pay-to-participate model in this study, aligning with Efforia's principles of respect for persons, transparency, and empowerment.
Human Subjects Protection Questionnaire
Beneficence
Is there a description, unambiguous research question, and purpose?
Yes, the study has a clearly defined research question and purpose. The study aims to investigate the effects of a specific product or service, focusing on its impact on participant health outcomes.Is the study built on what is known already?
Yes, the study builds on existing knowledge, utilizing previous research findings and data related to the product or service being evaluated. This foundation helps ensure the study is grounded in established scientific understanding.Will the study provide meaningful answers to the research question?
Yes, the study is designed to yield meaningful results that are both generalizable and relevant to the individual participants. By focusing on real-world applications and outcomes, it offers insights that contribute to both the scientific community and the participants themselves.Will the study provide valid answers to the research question?
Yes, the study employs rigorous methodologies to ensure valid and reliable results. The use of a decentralized trial design allows for collecting accurate and applicable data across diverse participant groups.
Non-maleficence
Are participants recruited with justifiable inclusion and exclusion criteria?
Yes, the study includes participants who have already purchased the product, making them eligible for participation. Efforia emphasizes participant responsibility in assessing the suitability of the protocol for them, facilitated by transparent risks and considerations outlined in the informed consent.Does the research team have the experience, skills, facilities, and time to complete the study?
Yes, the research team is well-equipped with the necessary experience, skills, and infrastructure. The decentralized study design minimizes patient interaction, reducing the risk of adverse events, while the extensive infrastructure of the Efforia platform, combined with the oversight of experienced professionals like Matthew Amsden and Dr. Viral Patel, ensures thorough management and support.Is there a fair balance of benefits and harms (risks) for all with an interest in the study?
Yes, the study's unique approach offers additional value to participants who have purchased the product at no extra cost. The minimal risk protocol further ensures that the potential benefits outweigh the risks, benefiting both participants and the broader research community.Will participants receive appropriate care both during and after the study?
Yes, participants are advised to seek their own medical care in the event of an adverse event, as outlined in the informed consent. The minimal risk nature of the interventions ensures participants receive more care than they would otherwise, with enhanced monitoring of adverse events.Is personal data handled appropriately (confidentiality)?
Yes, personal data is managed in accordance with the guidelines outlined in the Minimal Risk Umbrella protocol, ensuring participant confidentiality and data security.
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 participants with clear and comprehensive information about the study, including its risks, benefits, and voluntary nature, enabling them to make informed decisions about their participation.Has the research incorporated patient and participant views?
Yes, the study is participant-driven, reflecting Efforia's commitment to incorporating participant perspectives. It encourages feedback and questions from participants, ensuring their views are integrated throughout the study.
Justice
Are there fair payments for participation and financial recompense in case of harm?
Yes, participants pay to participate, but they receive valuable products and health tracking, which offer intrinsic value. In case of adverse events, they are instructed to seek medical care at their expense and report the incident to Efforia.Do participants have access to an independent complaints procedure (or advocate)?
Yes, participants can contact Efforia's support for any concerns, and the informed consent includes contact information for an independent ethics review board, providing an avenue for addressing complaints independently.Will the project be registered and results reported in the public domain?
Yes, Efforia commits to transparency by making personal results immediately available to participants and publishing generalizable results to build credibility and contribute to the scientific community.