- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06634914
30-Day MoonBrew Sleep & Stress Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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.
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- US-based participants
Exclusion Criteria:
- allergies to mushrooms or adaptogens
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Moonbrew 30 Days
30 Days of the Moonbrew Sleep cocktail consumed before bed.
|
A blend of adaptogens with Chamomile, Rose, and Magnesium in a powdered form, designed to be mixed in liquid and consumed 2-3 hours before bed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PROMIS Sleep Disturbance Scale
Time Frame: 30 days
|
The PROMIS Sleep Disturbance Scale is a validated and widely used assessment tool developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative.
It is designed to measure the severity of sleep disturbances and disruptions experienced by individuals.
This scale includes a range of questions that assess the frequency and impact of various sleep-related issues, such as difficulty falling asleep, nighttime awakenings, and restless sleep.
Healthcare professionals and researchers rely on this scale to better understand and quantify sleep problems in patients, enabling them to tailor interventions and treatment strategies to address sleep-related concerns effectively.
|
30 days
|
|
NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form Survey: NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form Survey Score
Time Frame: 30 Days
|
The NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form Survey is a standardized psychological assessment tool developed by the National Institutes of Health (NIH) to measure an individual's perceived stress levels.
It is intended for use in adults aged 18 and above and is designed to provide a reliable and consistent measure of perceived stress.
The fixed form survey includes a set of questions that assess an individual's subjective experiences related to stress, allowing healthcare professionals and researchers to gauge stress levels and its potential impact on overall health and well-being.
This tool is a valuable resource for evaluating and monitoring stress in various clinical and research settings.
|
30 Days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13210
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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