30 Day

30-Day MoonBrew Sleep & Stress Study

STUDY TITLE 30-Day MoonBrew Sleep & 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

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Study author

Alejandro Facundo, andrew case

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

The study involves participants consuming MoonBrew every evening to enhance sleep quality and reduce stress. Participants will drink MoonBrew 1-2 hours before their planned bedtime to assess its effects on sleep patterns and stress levels over a 30-day period.

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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 study:

Poor sleep and high stress levels are pervasive issues affecting millions globally, leading to significant health problems. Research has consistently shown that poor sleep quality can exacerbate stress, while high stress levels can further disrupt sleep patterns. We have some great anecdotal evidence that suggests Moonbrew really works. This study aims to bridge the gap between anecdotal evidence and scientific evidence.

My Objective for You:

My objective for you is to evaluate how consuming MoonBrew each evening for 30 days affects your sleep quality and stress levels. By participating, you will contribute valuable data that could help others seeking natural solutions for better sleep and stress relief.

Aims & Objectives:

The aim of this study is to scientifically assess the impact of MoonBrew on sleep quality and stress levels using the PROMIS Sleep Disturbance Scale and NIH Toolbox® Item Bank v3.0 – Perceived Stress survey. Our objective is to determine whether regular consumption of MoonBrew can significantly improve sleep patterns and reduce stress over a 30-day period.

Significance & Impact:

This study is significant as it seeks to provide scientific evidence on the efficacy of MoonBrew, a popular natural remedy, in enhancing sleep quality and reducing stress. Expected outcomes include improved sleep patterns and lower stress levels among participants. However, limitations include self-reported data and individual variations in response to MoonBrew. Nonetheless, the findings could pave the way for evidence-based recommendations and broader acceptance of natural sleep aids.

The Intervention

Over 30 days, participants will drink MoonBrew 1-2 hours before bedtime to evaluate changes in sleep patterns and stress levels.

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

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