30 Day

30-Day MoonBrew Sleep and Stress Study

STUDY TITLE 30-Day MoonBrew Sleep and Stress Study
Submitted under umbrella

Minimal Risk Citizen Science Umbrella Protocol

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

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Author edit

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Informed consent

Review

Study author

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

This study evaluates the effects of daily consumption of MoonBrew on participants’ sleep quality and stress levels over a 30-day period. Participants will consume MoonBrew each night before bedtime, aiming to assess changes in sleep patterns and perceived stress.

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

$48

Included products & services
MoonBrew – 30 Servings: $48
Outcome measures

PROMIS Sleep Disturbance Scale

NIH Toolbox® Item Bank v3.0 – Perceived Stress (Ages 18+) – Fixed Form 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”

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:

Sleep disturbances and stress are prevalent issues affecting adults in the United States, impacting overall well-being and productivity. Academic research has shown that natural supplements can positively influence sleep quality and stress reduction. Social media and popular press often tout the benefits of various herbal blends, creating a buzz around products like MoonBrew. This challenge combines credible scientific measures with the excitement of a social media challenge to evaluate the real-world impact of MoonBrew. It’s important to run this study to bridge the gap between anecdotal claims and scientific evidence.

My Objective for You:

My objective is for you to experience measurable improvements in your sleep quality and stress levels by participating in the 30-Day MoonBrew Sleep and Stress Study. Together, we aim to validate the benefits of MoonBrew through credible, standardized assessments.

Aims & Objectives:

The aim is to assess the impact of daily MoonBrew consumption on participants' sleep quality and stress levels over 30 days. Objectives include quantifying changes using the PROMIS Sleep Disturbance Scale and NIH Toolbox® Perceived Stress Survey.

Significance & Impact:

This challenge could significantly impact how we approach natural solutions for sleep and stress. Expected outcomes include improved sleep patterns and reduced stress levels, validated through reliable metrics. Limitations include participant adherence and individual variability in response to the supplement.

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:

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

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