Here is a little more information about the study. If you consent to participate in the study please check 'YES' on the next page.
Contact details for the study:
Dr Georgia Cook (gcook@brookes.ac.uk)
Oxford Institute of Applied Health Research
Oxford School of Nursing and Midwifery
Jack Straw's Lane, Marston
Oxford, OX3 0FL, UK
Professor Luci Wiggs (lwiggs@brookes.ac.uk)
The Centre for Psychological Research,
Faculty of Health, Science and Technology
Oxford Brookes University,
Headington campus,
Oxford, OX3 0BP, UK
Study title: The relationship between parents’ thoughts, sleep-related practices and children’s sleep
You are being invited to take part in a research study, which is a collaboration between Nanit and Oxford Brookes, to help us understand more about the relationship between how parents think, feel and behave and children’s sleep. Before you decide whether or not to take part, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully.
What is the purpose of the study?
This study aims to better understand the different factors that affect child sleep. We know that many factors can influence how well a child sleeps. This includes those things related to the child (such as age, temperament or health), related to the people around them (such as parenting and family routines) and related to the environment (such as noise, light or temperature). This study aims to better understand the different factors that affect child sleep. We are especially interested in how parents’ thoughts and feelings about their own and their child’s sleep relate to the sleep-related practices they use and the sleep of their child.
Why have I been invited to participate?
You have been invited to participate because you own and have registered a Nanit baby monitor device using your email address. In the current study we are seeking parents who take primary responsibility for their child (12–24-month-old) overnight and who live in the United Kingdom, Europe, the United States of America, Australia, New Zealand or Canada. You will need to be able to read and write in English to complete the questionnaires and have been using your Nanit device over the previous two weeks for your child’s nighttime sleep. If your child has a severe medical, developmental or psychiatric condition or is taking medication which could affect their sleep your family would not be eligible to take part. We are hoping that around 1000 families across the world will take part.
Do I have to take part?
It is up to you to decide whether or not to take part in this research study. If you do decide to take part, along with this information sheet, you will be given a privacy notice that will explain how your data will be collected and used and be asked to give your consent electronically. If you decide to take part, you are still free to withdraw at any time and without giving a reason. Any data collected from you can be withdrawn, up to the point of data analysis. If you wish to withdraw your data, please contact maristella.lucchini@nanit.com. Choosing to take part or not in this study will have no impact on your current or future relationship with or services provided by Nanit.
What will happen to me if I take part?
After you have read this information sheet and the privacy notice, if you have any questions, you can contact the research team. If you decide you wish to take part, we will ask you to give your consent electronically on the next page (by ticking checkboxes). You will then be asked to complete the online questionnaire portion of the study, where you (the child’s main night-time caregiver) will be asked some questions about yourself and your child, including your thoughts, feelings and behaviours related to your own and your child’s sleep. This will take no longer than 20 minutes to complete. Nanit will then generate numeric sleep summary data only (no video or other data) of your child’s sleep, using the data collected by the device for the past two weeks. In this study we are interested in:
- Night-time sleep duration: How many minutes your child sleeps during the night
- Night wakings: How many times your child wakes for 3 minutes or more during the night
- Time awake at night: The total number of minutes your child is awake during the night
- Parental visits: How many times a parent comes into your child’s sleep area during the night
- Bedtime: What time your child is first put to bed for the night
- Wake-up time: The child your child awakes for the final time in the morning
Your questionnaire responses and your child’s summary sleep data will be linked together (by Nanit) using your email address. Once the data are linked, anything identifying (such as your email addresses and IP address) will be removed. Each participating family will then be assigned a unique study ID number. Only this pseudonymised dataset will be prepared by a Clinical Research Data Analyst and checked by another member of the Nanit research team) will be shared securely with the researchers at Oxford Brookes University. Throughout the research no encryption key or information enabling re-identification will be shared between the parties (OBU & Nanit) to identify the personal information. Please be assured that Oxford Brookes University will not take any steps to identify you and will treat your information as anonymous.
What are the possible disadvantages and risks of taking part?
The main disadvantage is that participating in the study will take up some of your time. We estimate it will take around 20 minutes to complete the questionnaires. All the questionnaire assessments used in this study have been used in many other studies with parents and children and there have been no reported problems associated with their use.
It is possible that some people may find it upsetting to answer questions about their child’s sleep, if reflecting on their child’s sleep and any associated problems is distressing. If you are distressed you can take a break or stop at any time by closing your web browser. At the end of this information sheet (and repeated at the end of the questionnaires) are some evidence-based informational resources and support organisations that you may wish to consider contacting if you require any further information or support. If you have any major concerns about your child’s sleep, please consult a healthcare provider.
What are the possible benefits of taking part?
There are no direct benefits to you for taking part. However, you will be contributing to furthering our scientific understanding about parenting and children’s sleep. Participants who take part in this study can be entered by Nanit into a random prize draw for one of two yearly Insights subscriptions. Winners will be chosen at random by Nanit upon completion of the study and announced via Nanit social media platforms.
Will what I say in this study be kept confidential?
The data collected and stored as part of this research study will be kept strictly confidential, within the limitations of the law. Both Nanit and Oxford Brookes University are acting as an independent data controller. Nanit will collect all raw data securely via Alchemer (questionnaires, see privacy notice for more details on how this platform and how it collects and stores your data) or Internal Database (sleep data) and once downloaded a copy of the dataset will be stored on Amazon Cloud Storage (AWS3), with whom Nanit have a paid for secure account. See privacy notice for more details on how Nanit collects and stores your data for this project. Researchers at Oxford Brookes University will receive a pseudonymised data set for analysis purposes only with no possibility of sharing of the encryption key to re-identify the personal data or information enabling re-identification by Oxford Brookes University. Data will be transferred securely using a shared password-protected Google Drive, for which Oxford Brookes University has a version with enhanced security protocols. Only the researchers (at Nanit and Oxford Brookes) will have access to this data and it will be securely stored on this password-protected Google drive. A version of the data will also be stored on institutional laptops for analysis purposes. All laptops and computers used to access Google drive and store data are also password-protected. You will not be identifiable in any publication or presentation resulting from this study as we will remove all apparent personal identifiers.
In line with Oxford Brookes University policy, we will store an electronic anonymous data set for 10 years on Oxford Brookes University’s secure institutional archiving platform Arkivum. We will also collate an anonymous data set which is available for sharing for collaborative research purposes with sleep researchers in credible academic research environments, upon request and with the agreement (including new data transfer agreement as necessary) with the project team and Nanit Lab scientific team based on receipt of a relevant research proposal.
What should I do if I want to take part?
If after you have read this information sheet and the privacy notice, you wish to take part, please click ‘next’ at the bottom of the page where you will then, on the next page, be asked to provide your consent electronically (by ticking checkboxes). Once you have done this you will then be able to access the online questionnaire portion of the study on the following page. Once you submit your questionnaire data, Nanit will generate numeric sleep summary data only (no video or other data) of your child’s sleep, using the data collected by the device for the past two weeks.
What will happen to the results of the research study?
We will write up results of the research study and plan to disseminate this in academic publications and via conferences. We will produce a summary of the findings which Nanit will disseminate via their website and social media channels, so you will be able to access a summary of the results once they are available and published. We will also share the summary on the professional social media pages of the researchers on the project. Any data included in publications, conferences or summaries will be anonymised and no individual or family will be identifiable.
Please note: Publications such as journal articles, books, theses or dissertations are increasingly made available in digital repositories, and will typically be freely available online. The researchers will take particular care to ensure all personal details are fully anonymised.
Who is organising and funding the research?
This project involves a collaborative relationship between researchers at Oxford Brookes University (Dr Georgia Cook, Research Fellow in the Oxford Institute of Applied Health Research and Professor Luci Wiggs, Professor in Psychology) and Nanit Lab (Dr Maristella Lucchini, Senior Clinical Research Consultant and Dr Natalie Barnett, Vice-President of Clinical Research). The partnership is solely for research purposes. The only associated financial transaction is that researchers at Oxford Brookes University have supplied a small amount of funding to the project to pay for social media adverts used by Nanit in the recruitment phase of the study. Nanit Lab is contributing data, whilst researchers at Oxford Brookes are contributing research design, analysis and dissemination expertise. This relationship and research project does not imply endorsement of any product or service.
There is no funding associated with the research study.
Who has reviewed the study?
This study has been reviewed and approved by Health & Social Care Research Ethics Sub-Committee (HSCRES) on behalf of the University Research Ethics Committee, Oxford Brookes University. Registration number: 251939
Contact for Further Information:
If you have any questions or would like any additional information about the study, please contact the principal researcher Dr Georgia Cook (gcook@brookes.ac.uk).
If you have any concerns about the way in which the study has been conducted, you should contact the Chair of the University Research Ethics Committee on ethics@brookes.ac.uk.
If you would like further information about sleep the below international websites should be useful:
Baby Sleep Information Source: https://www.basisonline.org.uk/
Pediatric Sleep Council: https://www.babysleep.com/
World Health Organization (WHO): https://www.who.int/tools/your-life-your-health/life-phase/newborns-and-children-under-5-years/making-sure-newborns-and-children-under-5-years-sleep-safely
If, after looking at these resources, you have any concerns about your or your child’s sleep, please speak to you/your child’s doctor or healthcare provider.
Thank you for taking time to read the information sheet.