What You Need to Know to Participate
This document provides information to help you decide whether to join this research study. It is important you understand the responsibilities, risks and benefits of participating.
Summary Information to Help you Decide Whether to Join this Study
| Study Title | Enhancing Sleep Quality with Natural Sleep Drops and Stretching |
|---|---|
| Study Author | Matthew Amsden |
| Sponsor | This study is made possible by your payment to join. |
| Cost of Products, Services & Information to Participant | $0 |
| Included Products & Services | Natural Sleep Drops (Extra Strength), Oura Ring |
| Outcome Measures | Oura Sleep, PROMIS Sleep Disturbance Scale, |
| Contact | help@efforia.com |
Introduction & Summary
Welcome to the Enhancing Sleep Quality with Natural Sleep Drops and Stretching research study hosted on the Efforia platform. Your participation is crucial in advancing our understanding of how natural interventions can improve sleep quality. This document provides essential information to help you decide whether to join. Participation is voluntary, and you may leave the study at any time without penalty. Please ensure all your questions are answered before you proceed.Purpose of the Study
This study aims to explore whether Natural Sleep Drops (Extra Strength) combined with a nightly light stretching routine can enhance sleep quality. By using the Oura Ring and the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale, we aim to gather data that could contribute to scientific knowledge about sleep improvement methods. Natural Sleep Drops are formulated to support deeper and more restorative sleep, while stretching helps to relax the body and mind before bedtime.What You Will Do as Part of this Study
While participating in this research study, you will need to:
- Be willing and able to follow the study directions and procedures
- Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
- Ask questions as you think of them, via help@efforia.com or online chat.
- Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.
Participant Responsibilities and Tasks
Welcome to the Enhancing Sleep Quality with Natural Sleep Drops and Stretching Challenge, a carefully designed eight-week program aimed at improving your sleep quality. Your participation is integral to the study, and your adherence to the assigned tasks is crucial for obtaining accurate results.
Overall Schedule and Timeline
This program spans eight weeks, during which you will integrate Natural Sleep Drops (Extra Strength) and a light stretching routine into your nightly regimen. Your progress will be tracked through the Oura Ring and the PROMIS Sleep Disturbance Scale.
Treatment Activities
- Natural Sleep Drops Routine: Incorporate the use of Natural Sleep Drops into your nightly routine to enhance deep and REM sleep.
- Light Stretching Routine: Perform a light stretching routine each night to aid in relaxation and improve sleep quality.
Measurement and Frequency
- Baseline Measurements: Conduct initial assessments using the Oura Sleep Score and the PROMIS Sleep Disturbance Scale to establish a starting point.
- Weekly Assessments: Each week, measure your sleep quality using the Oura Sleep Score and the PROMIS Sleep Disturbance Scale to monitor progress.
It is imperative to adhere meticulously to the timeline and schedule to ensure the accuracy and reliability of the study's findings. Your commitment and consistency are greatly appreciated as we explore the benefits of these natural interventions.
The Risks, Discomforts & Benefits of Being in this Study
There are some unique risks, discomforts, and potential benefits of being in this study that you should understand.Consider your Own Risk-Benefit Comfort Level
It is important to thoroughly weigh the risks and benefits of participation. We are placing more responsibility on you to make the right choice than in a traditionally sponsored trial. It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.Personal and Overall Findings
Efforia will provide you with both personal outcomes as well as overall findings. These findings will be made available at various data collection points in your experience in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved in the study. Remember, participation is voluntary and you may exit at any time with an e-mail to help@efforia.com.Possible Benefits of Participation
You may experience improved sleep quality and gain insights into personal health metrics through the use of the Oura Ring and the PROMIS Sleep Disturbance Scale. Additionally, by contributing to this research, you will help advance scientific understanding of natural sleep interventions. However, there is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention or treatment had no measurable impact.Possible Serious Adverse Events & Side Effects
Risk Assessment for Natural Sleep Drops (Extra Strength) and Oura Ring
Introduction and Summary of Known Risks
The use of Natural Sleep Drops (Extra Strength) combined with the Oura Ring for monitoring presents several risks and side effects, ranging from minor to potentially serious. These risks include allergies to ingredients in the sleep drops (undefined due to lack of specific ingredient information), side effects from misuse or overuse, and potential interference or inaccuracies in data collection by Oura Ring. The maximum dosages for the Natural Sleep Drops have not been explicitly provided, requiring cautious use to avoid potential toxicity.
The following is a summary of known risks. However, research is limited, and there may be risks not covered by this document, risks that are currently unknown or unforeseen. Please consider these risks carefully, do your own research, and talk to a professional who knows you well and has expertise in this area, like your personal physician.
In the Case of an Adverse Event
In the event of experiencing any severe reactions, such as difficulty breathing, severe rash, or a significant change in mental state, it is crucial to seek immediate medical attention by calling 911. Once any acute situation has been managed, participants are encouraged to contact Efforia to report the event, ensuring that all necessary support and documentation are provided.
Serious Adverse Events (SAEs)
| Theoretical side effects | Relative incidence | Recovery |
|---|---|---|
| Allergic reactions (e.g., anaphylaxis) | Very low likelihood | Corrects after discontinuation |
| Severe sleep disturbance | Low likelihood | Corrects after discontinuation |
| Dependency or withdrawal symptoms | Low to moderate likelihood | Potentially permanent without intervention |
| Incorrect data reporting leading to misdiagnosis or improper treatment | Moderate likelihood | Corrects after discontinuation of use |
| Frustration and irritation | Low to moderate likelihood | Corrects after discontinuation |
Efforia's limitations in providing direct medical support
Efforia provides technological and data support but lacks the infrastructure to offer direct medical intervention. Participants should maintain regular contact with healthcare providers.
Long-term Dependence
Long-term dependence on Natural Sleep Drops (Extra Strength) could potentially develop, especially if used excessively without professional supervision. It is important to monitor usage patterns and consult healthcare providers to avoid dependency.
Legality for Use by Various Institutions
The use of Natural Sleep Drops and the Oura Ring must comply with regulations set by various institutions. For instance, athletes should verify the acceptance of these products under the World Anti-Doping Association (WADA) and National Collegiate Athletic Association (NCAA) rules. Additionally, usage should align with general Corporate Workplace policies regarding health and wellness products to ensure that use does not conflict with employment conditions or expectations.
Privacy & Security Risks
We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as no risk. Potential participants should review the Efforia general privacy policy, which is available here: https://efforia.com/privacy-policy/ There may be very certain limits to the rights of your privacy:- We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
- Regulators, like the FDA or similar agency, or Institutional Review boards may review records that have your identifying information.
What to do if you have a study related injury.
Seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia if you experience any problems, have any side effects, or have any study-related injury after you've received any necessary treatment. We want to make sure others are aware of potential risks.Study related injury care and compensation
Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.
In the case of medical emergency
In the case of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately. If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.