30 Day

Sleep Improvement with Sontrava Tea

STUDY TITLE Sleep Improvement with Sontrava Tea
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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Informed consent

Review

Study author

Ivan Fedkiv

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

This protocol involves the nightly consumption of Sontrava tea, known for its calming and sleep-promoting properties. Participants will prepare and drink the tea 30 minutes before bedtime, which may aid in improving overall sleep quality and duration.

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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

$0

Included products & services
Strava App: $99
Outcome measures

Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)

Oura Activity

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:

Sleep difficulties are prevalent among adults in the United States, often leading to poor mental and physical health outcomes. Scholarly research demonstrates the efficacy of natural remedies, such as herbal teas, in promoting relaxation and better sleep. Social media and popular press frequently praise the calming effects of Sontrava tea. The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) and Oura Activity metrics offer robust ways to measure improvement. This study aims to validate these claims and provide evidence-based recommendations.

My Objective for You:

The goal of this challenge is to help you improve your sleep quality and duration by incorporating Sontrava tea into your nightly routine. By participating, you will potentially experience enhanced mental well-being and physical health, as measured by WEMWBS and Oura Activity metrics.

Aims & Objectives:

The aim is to assess the efficacy of Sontrava tea in improving sleep quality and duration among adults with sleep difficulties. The objective is to measure changes in mental well-being and physical activity from Baseline to endpoint using WEMWBS and Oura Activity.

Significance & Impact:

This challenge could provide a simple, natural solution to sleep difficulties, improving overall well-being. Expected outcomes include enhanced sleep quality, better mental health, and increased daily activity levels. Limitations include individual variability in response to Sontrava tea and adherence to the protocol.

The Intervention

Included Products & Services

Product Name: Strava App

Quantity included: 1

Price: $99.00

Product Description: Strava App test

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