56 Day
Nightly MoonBrew Ritual for Sleep Improvement
STUDY TITLE | Nightly MoonBrew Ritual for Sleep Improvement |
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Submitted under umbrella | |
Date submitted |
- |
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 |
Matthew Amsden |
Principal investigator |
Matthew Amsden |
Sub-Investigator for Adverse Events |
Dr. Viral Patel |
Description |
Participants will engage in a nightly ritual where they consume a serving of MoonBrew 30 minutes before bedtime. This intervention aims to enhance sleep quality through the natural ingredients formulated in MoonBrew that support deep and restful sleep. |
Participant engagement length |
56 Days |
Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
Cost to participant |
$96 |
Included products & services |
MoonBrew – 30 Servings: $48
Apple Watch: $0
Adam Sensor – Nocturnal Erection Tracker: $149
|
Outcome measures |
PROMIS Sleep Disturbance Scale Apple Watch Sleep Tracking Adam Sensor: Nocturnal Penile Tumescence |
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” |
Yes |
Recruitment jurisdictions |
United States, United Kingdom |
Clinicaltrials.Gov |
Yes |
Committment to list findings on clinicaltrials.Gov |
Yes |
This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Why I created this challenge:
The Nightly MoonBrew Ritual for Sleep Improvement is designed to address the significant issue of sleep disturbances among adults in the U.S. Academic research and social media alike highlight the pervasive struggles with sleep and the quest for natural solutions. Studies suggest potential benefits of certain natural ingredients in enhancing sleep quality, yet robust evidence remains scant. This challenge seeks to scientifically validate the efficacy of MoonBrew in improving sleep, leveraging both state-of-the-art technology and traditional wisdom. It's crucial to offer evidence-based, natural interventions for better sleep health.
My Objective for You:
My goal is to empower you to significantly enhance your sleep quality through a structured and enjoyable ritual. By participating in this challenge, you will not only contribute to important scientific research but also experience firsthand the potential benefits of MoonBrew on your sleep patterns.
Aims & Objectives:
This challenge aims to rigorously assess the impact of the nightly consumption of MoonBrew on sleep quality using validated tools and advanced tracking technologies. Our objective is to determine whether this ritual can lead to measurable improvements in sleep metrics including duration, efficiency, and satisfaction.
Significance & Impact:
By participating in the Nightly MoonBrew Ritual for Sleep Improvement, you are at the frontier of exploring a potentially transformative solution for sleep disturbances. The findings could pave the way for new, natural sleep aids supported by empirical data, offering a significant contribution to sleep medicine. While we anticipate revealing important insights, the limitation lies in the variability of individual sleep patterns and external influences that might affect outcomes.
The Intervention
Included Products & Services
Product Name: MoonBrew – 30 Servings
Quantity included: 1
Price: $48.00
Product Description: A calming and soothing blend of adaptogens with Chamomile, Rose, and Magnesium to help you catch the ZzZ's and stay asleep. Sleep tight and wake up refreshed. - 30 Servings of MoonBrew
Product Image:
Ingredients:
Bai Zi Ren extract
Juan Fu Ling extract
Yuan Zhi extract
Bai He extract
N/a spearmint
Lavender extract
L-Theanine
Lemon Balm extract
Chamomile extract
Jujube seed extract
Turkey Tail extract
Reishi Extract
Valerian Root
Magnesium glycinate
Product Safety:
MoonBrew is designed to support sleep quality and stress reduction. It incorporates a variety of herbal extracts and compounds known for their potential benefits in these areas. However, as with any treatment, there are risks associated with its use. This document outlines these risks, based on available data from academic research, anecdotal evidence, and theoretical concerns.
Possible adverse events associated with MoonBrew include a range of theoretical side effects. These may encompass allergic reactions (such as rash, itching, swelling, dizziness, or difficulty breathing), which can vary in incidence and typically resolve after discontinuation. Gastrointestinal discomfort, including diarrhea, nausea, and stomach cramps, is considered to have a moderate incidence and usually subsides upon stopping use. Sedation and drowsiness are also moderately common. Interactions with medications, while less frequent, can occur and their resolution depends on the specific medication involved. Other potential effects include hormonal changes, sleep disturbances (like changes in sleep patterns, insomnia, or vivid dreams), blood pressure alterations, and impacts on the immune system. These effects generally have a low to moderate incidence and often resolve after discontinuing MoonBrew. Some users might experience frustration or irritation with the study experience, though this is relatively uncommon. It's important to note that the recovery from these side effects can vary, with most resolving after discontinuation of the product, while others may require monitoring or management as per medical advice.
Long-term Dependence
Long-term dependence on MoonBrew is unlikely due to its composition of vitamins and herbs and short treatment duration. However, psychological dependence on its effects cannot be entirely ruled out.
Legality and Compliance
MoonBrew’s ingredients are generally recognized as safe and legal. Its use should comply with regulations of relevant governing bodies such as the World Anti-Doping Association, National Collegiate Athletic Association, and general Corporate Workplace standards. Consult these entities if your participation in sports or employment is subject to specific substance use policies.
This assessment aims to provide thorough information on the risks associated with MoonBrew, but may not be complete. There may be unknown risks at this time. All participants are encouraged to monitor their health closely and report any concerns to their healthcare provider and Efforia.
Product Name: Apple Watch
Quantity included: 0
Price: $0.00
Product Description: Efforia can pull in data from your existing Apple Watch such as sleep and activity data. Please see other retailers to purchase a device if you do not have one.
Product Image:
Ingredients:
Product Safety:
Product Name: Adam Sensor – Nocturnal Erection Tracker
Quantity included: 1
Price: $149.00
Product Description: You monitor your steps, calories, and even your credit score. Now, it's time to keep an eye on something crucial for many—your manhood's health. The Adam Sensor offers advanced technology to track erection health and gives you a chance to join leading studies in male wellness, uncovering new insights.
Product Image:
Ingredients:
Product Safety:
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Study Design & Experience
Statistical Analysis Plan
Limitations & Justification
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
Suitability for Pay to Participate Model
Human Subjects Protection Questionnaire
Logging
Logging
Date | Event | Message | Name |
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Oct 08, 2024 12:55:19 | modified | alejandro | |
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Oct 08, 2024 12:52:13 | modified | alejandro |