90 Day
Sleep Enhancement with Sleepwhale Drops
| STUDY TITLE | Sleep Enhancement with Sleepwhale Drops |
|---|---|
| Submitted under umbrella | |
| Date submitted |
Mar 25, 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 |
Devin Shendell |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
Join our 90-day trial and transform your sleep with SleepWhale Natural Sleep Drops, designed for U.S. residents seeking enhanced sleep quality and recovery. Experience improved vitality and reduced fatigue by taking three drops under the tongue nightly, 30 minutes before bed. Track progress using PROMIS Sleep Disturbance and Fatigue Scales. Sign up now to sleep better and feel rejuvenated! |
| Participant engagement length |
90 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$0 |
| Included products & services |
SleepWhale Natural Sleep Drops: $97
|
| Outcome measures |
PROMIS Sleep Disturbance Scale PROMIS Short Form v1.0 – Fatigue 8a |
| 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:
Sleep quality is a crucial component of overall health, yet many struggle with disturbances and fatigue. While academic research highlights the physiological benefits of natural supplements in promoting restful sleep and reducing fatigue, social media and popular press often share mixed claims about their efficacy. Sleepwhale Drops, crafted from natural ingredients, promise to enhance sleep quality and vitality. By conducting this study, we aim to substantiate these claims with empirical evidence and offer a scientifically-backed solution for those seeking better sleep.
My Objective for You:
My objective is to guide you through a transformative sleep journey using Sleepwhale Drops, enhancing your vitality and reducing fatigue. We will closely assess improvements using the PROMIS Sleep Disturbance Scale and Fatigue Form, aiming for measurable enhancements by day 35. Join us in this evidence-based challenge to awaken rejuvenated, redefine your nights, and revitalize your days.
Aims & Objectives:
This study aims to evaluate the efficacy of Sleepwhale Natural Sleep Drops in enhancing sleep quality and reducing fatigue. Our objective is to provide participants with quantifiable improvements in sleep disturbance and fatigue levels by the study's conclusion.
Significance & Impact:
The significance of this challenge lies in its potential to offer a natural, effective solution for improving sleep quality and reducing fatigue. Expected outcomes include enhanced vitality and reduced sleep disturbances, contributing to overall well-being. However, individual responses may vary, and further research may be needed to generalize findings. This study could pave the way for broader acceptance of natural sleep aids based on scientific evidence.
The Intervention
Included Products & Services
Product Name: SleepWhale Natural Sleep Drops
Quantity included: 1
Price: $97.00
Product Description: A 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:
Broad-spectrum nano-hemp (0.00% THC)
CBN isolate
Suntheanine (a form of L-theanine)
Gadomag+
M2 Lion's Mane
Sibelius (a proprietary Roman chamomile extract)
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.
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Pregnant or breastfeeding women | Potential harm to fetus or infant | Unknown effects on pregnancy or infant development. |
| Individuals with chronic illnesses | Potential exacerbation of underlying conditions | The intervention may interfere with existing treatments or conditions. |
| Individuals with a history of severe allergies | Risk of allergic reactions to intervention components | Potential for serious allergic reactions or anaphylaxis. |
| Individuals with mental health disorders | Possible mental health impact | Intervention may affect mental well-being or interact with medications. |
| Individuals taking contraindicated medications | Drug interaction risk | Potential for harmful interactions with the intervention. |
| Individuals with compromised immune systems | Increased vulnerability to side effects | Risk of infection or other complications from intervention. |
| Minors or individuals unable to consent | Informed consent requirement | Ethical concerns and legal requirements for informed consent. |
Each potential participant should carefully consider their personal health conditions and consult with a healthcare professional if they fall into any of these categories.