Information and consent form for AUD003

Study Title : Audicin and wellbeing                                                
Project number: AUD003


Background

Science has shown that Binaural Beat (BB) music can enhance wellbeing. The Audicin research lab, headed by Dr. Victoria Williamson, is observing how Audicin’s immersive BB music impacts on nurses.

Who is organizing and funding the research?

Audicin Oy is sponsoring the research using funds provided by Business Finland.

Who has ethically reviewed the project?

This project has been ethically assessed via Audicin’s ethics review board, who monitor the application and delivery of Audicin’s Ethics Review Procedure to be in line with those applied by UK University Ethics Review boards.

Who can participate in this study?

  • I am a registered nurse working in the US or UK.

  • I am not a night shift worker.

  • I own an iPhone running iOS 17 or 18. The oldest models are the iPhone XS, iPhone XS Max, and iPhone XR (from 2018).

  • I own an Apple Watch and would be willing to wear it day and night for the course of the 2 week study.

  • I am between the ages of 18 and 55.

  • I am not pregnant.

  • I have normal or corrected-to-normal hearing.

  • I have never been diagnosed with attention deficit hyperactivity disorder (ADHD).

  • I have never been diagnosed with post-traumatic stress disorder (PTSD).

  • I do not drink alcohol more than recommended guidelines as set by the National Center for Health Promotion and Disease Prevention (Female: No more than 1 drink in a single day and no more than 7 drinks per week. Male: No more than 2 drinks in a single day and no more than 14 drinks per week).

What will the participants and researchers be doing?

Our methods of communication will be email and phone for ongoing communication and direct queries. Your iphone will be set up with the AudicinResearch app so you can listen (background listening is fine!) to a minimum of 30mins of Audicin a day (maximum 2 hours).

The full study setup is as follows:

  • First we will help you download the Audicin Research app. 

  • Next complete online surveys about personality, musicianship, wellbeing, and productivity. This will take approximately 20 minutes.

  • For the next 2 weeks , listen to a minimum of 30 minutes of Audicin per day over headphones whenever suits you (maximum 2 hours).

  • After the 2 week listening period,repeat the online surveys that we sent to you by email, to see what has changed.

  • Finally, we will ask via email if you would like to take part in a follow-up interview. This is a separate study, entirely voluntary. If you would like to opt in then we would send details of the interview study and the monetary compensation on offer.

What data will be recorded?

Your data in the form of numbers, written replies, and audio, will be recorded in an anonymous password protected database. Any personal interactions with any individuals from Audicin will be strictly informal and will not be recorded. 

In addition, you will link your iPhone and Apple Watch to the Apple Health App. With your permission, we will access your Apple Health data in order to view a preselected number of health measures that may be impacted by Audicin use. Examples include: Heart Rate, Heart Rate Variability, Respiration Rate, and Step Count. The full list of measures is available in our Research and Development Privacy Policy, which can be viewed here https://www.audicin.com/research-and-development-privacy-policy 

What will happen to my data?

Your data – in the form of statistical summaries, text summaries and quantitative/ qualitative analysis - may form part of a publication, such as a journal paper. It may also be presented to the public or investors as part of ongoing development and outreach activities. In all cases no individual will be identifiable: all responses will be kept anonymous. 

Your data will be stored in 2 locations; in the Audicin datastore and in the Survey Monkey Store. We have a contractual agreement with Survey Monkey that commits them to providing an appropriate level of safeguards for your personal data. Survey Monkey stores data in the US and EEA and as such is compliant under the EU-U.S. Data Privacy Framework, the UK Extension and the Swiss-U.S, and  is subject to the investigatory and enforcement powers of the U.S. Federal Trade Commission. All data is encrypted in transit and at rest and industry best practice access control restrictions are in place to ensure that only the Researchers who we explicitly nominate can access the data. Survey Monkey’s Privacy Notice can be accessed here: https://www.surveymonkey.com/mp/legal/privacy/ . Following the end of the project all data will be transferred with maximum due diligence to the Audicin datastore. 

Once the study is complete we will transfer all data to our database to be securely stored in our EU data center for a period of time in line with the requirements of any journal that publishes our report or for a minimum of three years, whichever is longer. After the transfer of data, all study data in Survey Monkey will be deleted permanently.

Who will be able to see the data?

All data will be password protected and only visible to the Research Team. The data will never be reproduced without obtaining additional consent from the individuals involved.

What are the benefits of taking part in this research?

For participants who complete the 2 week study whilst wearing their Apple Watch day and night and complete questionnaires (pre and post the 2 week listening period), we will send a $100.00 bank transfer.

Please note - Due to restrictions from our funding agency we are unable to offer part compensation for incomplete data. This includes incomplete data from Apple Watch caused by not wearing the watch night AND day.

Participants are responsible for providing an invoice based on a template we will send, with valid US bank details for transfer of funds, which will occur within 1 month of completing the study. All participants are also responsible for paying any regional or national taxes due on this research income in their location.

Do I have to take part?

No, there is no obligation to take part. If you do decide to take part, you will be asked to sign a consent form. You may withdraw at any time without giving a reason and without any consequences for your future interactions with Audicin.  

Further details of Audicin’s privacy policy can be found here (https://www.audicin.com/privacy-policy-audicin) and our Research and Development privacy policy can be found here: https://www.audicin.com/research-and-development-privacy-policy

If you decide that you no longer wish to take part, please email either the research team (research@audicin.com) or contact the research coordinator directly, Kristina Hännikäinen, (kristina@audicin.com).

If you have any queries about the research then your first point of contact is Kristina Hännikäinen. If you need additional support then you can contact the Audicin CEO Laura Avonius  (laura@audicin.com).

Consent form

Please read the following statements and sign to indicate your consent.

1. I have read and understand the information sheet that explains Study AUD003.

2. I have read and understand Audicin’s privacy policy (https://www.audicin.com/privacy-policy-audicin) and Research and Development privacy policy for this study https://www.audicin.com/research-and-development-privacy-policy 

3. I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason and without any consequences, and I know how to do this.  

4. I understand that this study requires me to activate Apple Health on my iPhone and Apple Watch. I consent to the health data within this application being accessed by the Research Team for AUD003, exclusively for the reasons outlined in this document.  

5. I understand that I must complete each aspect of the 2 week trial in order to be eligible for $100 compensation. I understand that no exceptions can be made. 

6. I understand that if I have any questions about this study I may contact Chief Scientist Dr. Victoria Williamson (victoria@audicin.com) or CEO Laura Avonius (laura@audicin.com)

7. I understand that all my responses will be kept strictly confidential. I give permission for the research team to have access to my anonymous responses. I understand that my name will not be linked with the research materials, and I will not be identified or identifiable in the reports that result from the research.  

8. I agree to take part in AUD003.

By downloading the Audicin research app, you agree to have read and understood The Information & consent form and agree on the terms of the trial.