30 Day

Sleep and Stress Reduction Protocol with Sleepwhale

STUDY TITLE Sleep and Stress Reduction Protocol with Sleepwhale
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

Akash Warkhade

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

Participants will incorporate Sleepwhale Broad Spectrum Hemp into their nightly routine to evaluate its impact on sleep quality and stress levels. The intervention focuses on enhancing relaxation and reducing anxiety to potentially improve sleep quality. Participants will engage in daily use of the product in the evening to assess its benefits.

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

$0

Included products & services
Sleepwhale CBN (cannabinol): $38
Outcome measures

General Anxiety Disorder (GAD-7)

PROMIS Sleep Disturbance Scale

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”

No

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:

Stress and sleep disturbances are prevalent issues in the U.S., affecting daily life and overall health. Emerging research shows cannabinoids, like those in Sleepwhale, may improve sleep and reduce anxiety. Social media is buzzing with testimonials of better sleep and stress relief using hemp products, though scientific validation is limited. This challenge aims to bridge the gap by rigorously evaluating Sleepwhale's effectiveness, offering credible insights into its impact. It's crucial to understand how these products can be integrated into daily routines for tangible improvements in well-being.

My Objective for You:

My objective is to help you experience a noticeable reduction in stress and improvement in sleep quality by incorporating Sleepwhale into your nightly routine. By participating, you'll contribute to a greater understanding of how hemp products can enhance relaxation and reduce anxiety, potentially transforming your sleep experience and overall well-being.

Aims & Objectives:

The aim of this challenge is to evaluate the effectiveness of Sleepwhale CBN in reducing stress and improving sleep quality among adults. Our objective is to measure changes in anxiety and sleep disturbance scores from baseline to endpoint, providing valuable insights into the benefits of CBN.

Significance & Impact:

This challenge could revolutionize stress and sleep management by validating the efficacy of CBN products. Expected outcomes include reduced anxiety and improved sleep quality, while recognizing individual variability as a limitation. By participating, you'll help build a foundation for natural, hemp-based solutions to modern stress and sleep issues, potentially influencing future treatment paradigms.

The Intervention

Included Products & Services

Product Name: Sleepwhale CBN (cannabinol)

Quantity included: 30

Price: $38.00

Product Description: CBN is intended for nighttime use. Take 15 minutes before bedtime for deeper, more restful sleep. This product can be taken with Sleep Drops Regular or Extra Strength if you are looking for more sedation.

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