30 Day
Change in your anxiety levels yesterday
| STUDY TITLE | Change in your anxiety levels yesterday |
|---|---|
| Submitted under umbrella | |
| Date submitted |
Jun 8, 2025 |
| 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 | |
| Author edit | |
| Informed consent | |
| Study author |
Patrick Killen, Matthew Amsden |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
Ladies, discover if an air purifier can clear more than just the air. Dive into a 30-day journey to see if cognitive clarity, sleep serenity, and menstrual ease are within your grasp. Equip your living space with the Blue Pure 311i+ Max, track your sleep with Oura Ring, and let the data reveal the secrets. Are you ready to breathe new life into your well-being? Join us and find out. |
| 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 |
Oura Ring: $0
|
| Outcome measures |
Oura Sleep 36-Item Short Form Survey Instrument (SF-36) PROMIS® Scale v1.0 – Gastrointestinal Belly Pain 5a Survey |
| 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 |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Yada yada yada wowo hoo. Why I created this study:
In a world buzzing with pollutants and stress, the age-old quest for mental clarity, restful sleep, and menstrual ease has taken a modern twist. Recent studies hint at air purifiers offering more than just clean air—they might just be the unsung heroes of cognitive and hormonal harmony. While social media buzzes with anecdotes of clearer minds and smoother cycles, the science remains thin. Our study will cut through the fog, using hard data to reveal if breathing smarter truly elevates your well-being.
My Objective for You:
My goal is to empower you to discover whether an air purifier can transform your cognitive function, sleep quality, and menstrual experience. Over the course of 30 days, you'll track these vital aspects of your life using industry-leading tools. By the end, you'll hold personalized insights, helping you decide if the investment in an air purifier is worthwhile for your unique lifestyle and health journey.
Aims & Objectives:
This study aims to determine the tangible benefits of air purification on cognitive clarity, sleep quality, and menstrual health in women. Participants will gain unique, personalized insights into how these factors interplay with their well-being, equipping them to make informed lifestyle choices that impact time and financial investments.
Significance & Impact:
This study holds the potential to shift perceptions about indoor air quality's impact on mental and physical health. If successful, findings could pioneer a new frontier in home health optimization, though limitations such as individual variability and short study duration exist. Ultimately, you'll gain valuable data on how your environment influences your life, empowering smarter, healthier living decisions.
The Intervention
Included Products & Services
Product Name: Oura Ring
Quantity included: 1
Price: $0.00
Product Description:
Product Image:
Ingredients:
Product Safety:
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.
Based on the provided information, here is a table identifying the kinds of people who should avoid being part of this trial:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Individuals with severe allergies or asthma | Potential exposure to allergens during filter changes | While the device itself improves air quality, maintenance activities might expose individuals to allergens. |
| Pregnant individuals | Lack of specific safety data for pregnancy | Although minimal risks are involved, there's insufficient data on the effects of air purifiers during pregnancy. |
| Individuals with electrical sensitivity | Electromagnetic fields generated by the device | Some individuals may experience discomfort or symptoms from electromagnetic fields emitted by electronic devices. |
| People with severe cognitive impairment | Inability to provide informed consent and assess personal risk | Participants need to understand the study and assess risks, which may be difficult for those with severe cognitive impairments. |
| Individuals with rare respiratory conditions | Unknown impact on specific respiratory conditions | The effects of air purifiers on rare respiratory conditions may not be well-documented, posing unknown risks. |
| People with pacemakers or implanted electronic devices | Potential interference with device function | There could be concerns about interference from electrical devices, although air purifiers generally pose low risk. |
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
Beneficence
Is there a description, unambiguous research question, and purpose? Yes, the study clearly outlines the research question and purpose, focusing on understanding the effects of a specific product or service on participants who have independently chosen to purchase it.
Is the study built on what is known already? Yes, the study is designed based on existing knowledge of the product or service, leveraging prior research and consumer experiences to explore its efficacy and safety further.
Will the study provide meaningful answers to the research question? Yes, the study aims to generate results that are both generalizable and pertinent to individual participants, enhancing understanding of the product's effects.
Will the study provide valid answers to the research question? Yes, the study employs a rigorous design that ensures the validity of the findings, contributing valuable insights into the product's real-world application.
Non-maleficence
Are participants recruited with justifiable inclusion and exclusion criteria? Yes. Any individual who has already purchased the product is eligible to participate, with Efforia emphasizing participant responsibility to assess their suitability for the study through clear informed consent.
Does the research team have the experience, skills, facilities, and time to complete the study? Yes, the team is well-equipped, with the decentralized nature of the study requiring minimal patient interaction and a low likelihood of adverse events due to its minimal risk classification. Efforia's platform, combined with the expertise of Principal Investigator Matthew Amsden and Dr. Viral Patel, ensures comprehensive support and oversight.
Is there a fair balance of benefits and harms (risks) for all with an interest in the study? Yes, the study's approach under the minimal risk protocol provides participants with added value at no additional cost, balancing potential risks with benefits.
Will participants receive appropriate care both during and after the study? Yes, participants are advised to seek their own medical care in case of adverse events, but the study offers additional monitoring not typically available, enhancing participant safety.
Is personal data handled appropriately (confidentiality)? Yes, data confidentiality is assured, as outlined in the Minimal Risk Umbrella protocol.
Autonomy
Have participants been offered a fair choice through the information they are given (presented in plain English) and consent process? Yes, the informed consent document is comprehensive and clear, allowing participants to make an informed decision about their involvement in the study.
Has the research incorporated patient and participant views? Yes, the study is designed to include participant feedback, with Efforia's platform inherently focusing on participant-driven research.
Justice
Are there fair payments for participation and financial recompense in case of harm? Yes, participants pay to participate but receive valuable products and health tracking, with clear guidance to seek medical care for any adverse events at their own expense.
Do participants have access to an independent complaints procedure (or advocate)? Yes, participants can contact Efforia's support or use independent ethics review board contacts provided in the informed consent for complaints.
Will the project be registered and results reported in the public domain? Yes, Efforia ensures transparency by making results available to participants and aims to contribute to generalizable findings.