28 Day

4-Week Sleep Quality Enhancement Trial

STUDY TITLE 4-Week Sleep Quality Enhancement Trial
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

Preview

Author edit

Edit

Informed consent

Review

Study author

Pradeep Potu

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

Participants will utilize Sleepwhale Natural Sleep Drops daily for four weeks to potentially improve sleep quality. This intervention will focus on enhancing sleep patterns and overall restfulness. Participants will use the Sleepwhale Natural Sleep Drops as part of the intervention.

Participant engagement length

28 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 Natural Sleep Drops: $97
Outcome measures
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

The Intervention

Included Products & Services

Product Name: SleepWhale Natural Sleep Drops

Quantity included: 1

Price: $97.00

Product Description: A melatonin alternative. Crafted with natural herbs and minerals that target the most critical parts of the sleep journey for your best next-day self.

Product Image:

Ingredients: Broad-spectrum nano-hemp (0.00% THC)
CBN isolate
Suntheanine (a form of L-theanine)
Gadomag+
M2 Lion's Mane
Sibelius (a proprietary Roman chamomile extract)

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