Sleep Sub-study Fact Sheet
Study Title: NHS3 Sleep Sub-study
Principal Investigator: Dr. Tianyi Huang
Contact information: NHS3sleep@channing.harvard.edu or 617-525-2033
Purpose of this research
The purpose of this research is to use wearable devices (Fitbits) to monitor sleep and evaluate the impact of sleep behaviors on blood markers for cardiovascular and metabolic health.
The long-term goals of the research are to learn how various sleep schedules affect circadian rhythm in the general population and conduct a comprehensive investigation of sleep’s role in cardiometabolic disease risk.
Sponsor of this research
The study is funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health.
Who takes part in this research and why
About 1000 participants will take part in this research study. All subjects are also participants in the Nurses’ Health Study 3 and have provided a blood sample as part of the Chronic Disease Biospecimen Collection (CDBC). Many participants take part in this research because they believe cardiovascular and metabolic health are important topics of research. We couldn’t do this research without our participants.
Confidentiality and data security
Your privacy is important to us. The risks to participating are minimal given the protections in place to maintain confidentiality of information on the study’s computing system. These protections include uploading/transferring de-identified data through a secure cloud environment and maintaining data in a secure, password-protected computing system, which is kept totally separate from the contact information of study participants. Participant names and contact information reside on a separate server. Access to the data is provided through secure logins and granted on an as-needed basis per the Principal Investigator of the cohorts. The login can be deactivated by the IT team at any time. We have never experienced a breach in confidentiality.
Data sharing with other researchers
Your de-identified information may be used or shared with other researchers without your additional informed consent.
Data linkage with data from other studies
You may also be participating in a separate sub-study, the Chronic Disease Biospecimen Collection (CDBC), which we previously contacted you about. The encrypted data from the CDBC study will be received and stored by study investigators in our secure servers; investigators will be able to match participants’ blood samples with Fitbit and sleep diary data via your unique participant ID. Thus, the CDBC study data, data collected from this survey, and historical responses from Nurses’ Health Study 3 main questionnaires will be linkable via participant ID in future analyses.
Any risks associated with participation
The only foreseeable risk associated with this study is the unlikely and minimal risk of a breach of confidentiality. Protections are in place as described above.
Participation
Your participation is voluntary, and you can stop at any time. As always, not participating in a sub-study does not affect your status as a valuable member of the NHS3 main study. If you receive care at Mass General Brigham, deciding not to participate won’t affect medical care you receive at Mass General Brigham now or in the future, or any benefits you receive now or have a right to receive.
Participation involves:
- Completing a short online questionnaire on your sleep habits.
- Wearing an NHS3-provided Fitbit device for 14 consecutive days, including while you sleep.
- Sharing Fitbit data via Fitabase, an online platform that delivers your sleep data to our research team.
- Keeping a sleep diary for 14 days.
The Fitbit is yours to keep at the conclusion of the study.
Contact information for questions
If you have questions about this sub-study, please contact us at NHS3sleep@channing.harvard.edu or 617-525-2033
IRB contact information
If you would like to speak to someone not involved in this research about your rights as a research subject, or any concerns or complaints you may have about the research, contact the Mass General Brigham Human Research Committee at (857) 282-1900.
Privacy of Health Information
We are required by the Health Insurance Portability and Accountability Act (HIPAA) to protect the privacy of health information obtained for research. This is an abbreviated notice and does not describe all details of this requirement. During this study, identifiable information about you or your health will be collected and shared with the researchers conducting the research. In general, under federal law, identifiable health information is private. However, there are exceptions to this rule. In some cases, others may see your identifiable health information for purposes of research oversight, quality control, public health and safety, or law enforcement. We share your health information only when we must, and we ask anyone who receives it from us to protect your privacy.