40 Day

Cross-Over Study on MyVitalC ESS60 and Sleep Quality

STUDY TITLE Cross-Over Study on MyVitalC ESS60 and Sleep Quality
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

Chris Burres

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

Participants will engage in a cross-over design study, alternating between taking 5 ml of MyVitalC ESS60 in Olive Oil daily and not taking it for defined periods. They will complete a daily short-form sleep survey capturing sleep duration, perceived quality, ease of falling/staying asleep, and energy levels on waking. Wearable devices will be used to track metrics like total sleep duration, sleep stages, HRV, and recovery scores throughout the study.

Participant engagement length

40 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
Oura Ring: $0
Outcome measures

PROMIS Sleep Disturbance Scale

Oura Sleep

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: Oura Ring

Quantity included: 1

Price: $0.00

Product Description:

The Oura Ring is a piece of wearable technology designed to help you understand your body and improve your overall health. It is a small, lightweight ring that captures data from your body 24/7 and provides insights into your sleep, activity, and readiness. It is designed to be comfortable and discreet, and is made of hypoallergenic materials. The Oura Ring is a powerful tool that helps you to understand your body and make meaningful changes to your lifestyle.

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