NCT06634914

Brief Summary

This study aims to assess how consuming MoonBrew each evening for 30 days impacts sleep quality and stress levels. Poor sleep and high stress often go hand-in-hand, worsening overall health. By using validated self-reported outcome measures, this study bridges the gap between anecdotal evidence and scientific proof (without requiring a connected health device), contributing valuable insights into natural solutions for better sleep.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2025

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

October 8, 2024

Last Update Submit

October 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • PROMIS Sleep Disturbance Scale

    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

    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

Study Arms (1)

Moonbrew 30 Days

EXPERIMENTAL

30 Days of the Moonbrew Sleep cocktail consumed before bed.

Dietary Supplement: Moonbrew

Interventions

MoonbrewDIETARY_SUPPLEMENT

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.

Moonbrew 30 Days

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • US-based participants

You may not qualify if:

  • allergies to mushrooms or adaptogens

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm interventional.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 10, 2024

Study Start

October 15, 2024

Primary Completion

October 14, 2025

Study Completion

October 14, 2025

Last Updated

October 10, 2024

Record last verified: 2024-10