Mental HealthNCT06958523
Apple Health Study
An observational study of Mental Health and Sleep, run by Apple Inc. at 2 sites in United States.
Trial summary
The Apple Health Study aims to build a diverse and inclusive group of participants to help researchers advance our understanding of how signals and information collected from apps and devices relate to health and may be used to predict, detect, monitor, and manage changes in health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Sleep, Exercise
- How many people
- 500,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2025to Feb 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Study aims to enroll a large and representative group of at least 500,000 participants across the United States of America willing to contribute information about health and wellness over time.
Who may be able to join
- Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico);
- Live in the United States of America;
- Have an iPhone;
- Have installed Apple Research app on your iPhone;
- Be comfortable communicating in written and spoken English;
- Be willing and able to provide informed consent to participate in the Study.
Who cannot join
- Share your iCloud account, iPhone, or devices that collect health data such as Apple Watch with anyone else, because it could result in sharing another person's health information with the Study, making it challenging for researchers to use your information.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Angela Spillane, MS, applehealthstudy@bwh.harvard.edu
Calum MacRae, MD, PhD
- Recruiting
MCRA
Washington D.C., District of Columbia, 20001
Study Call Center, 833-600-6993
Tiffany Avery, MD
About this study
The Apple Health Study aims to build a diverse and inclusive group of participants to help researchers advance our understanding of how signals and information collected from apps and devices relate to health and may be used to predict, detect, monitor, and manage changes in health.
To enroll, US residents who have an iPhone can download the Apple Research app from the App Store and go through the introduction and informed consent for the Apple Health Study. This study is fully remote, and all are invited to enroll if the eligibility criteria are met.
Read more
Participants will be asked to complete tasks and surveys, using their iPhone and Apple Research app which include:
- Selecting the types of data they would like to share with the study such as health and sensor data
- Completing tasks and surveys including areas such as personal demographic information, personal medical history, family history, and social determinants of health
- Conditions
- Mental Health, Sleep, Exercise, Hormones, Metabolic Health, Hearing
- Keywords
- Apple Health Study, Large Scale Digital Study, Digital Biomarkers, Research App, Apple Research App, iPhone
- Medical subject headings
- Psychological Well-Being, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Status
Assessed by participant self-report as well as clinical health records and claims data. The initial count and change over time in the number and type of health conditions such as cardiovascular, circulatory, cognition, hearing, mental health, metabolic, mobility, neurologic, respiratory, sex and gender, reproduction, hormones, sleep, and health events such as hospitalizations, procedures or falls.
Measured: Baseline and every 6 months until study end (up to 5 years)
Secondary outcomes (3)
Participant Population: Demographic Characteristics of Study Participants
Results of surveys to report participant demographics.
Measured: Baseline and annually until study end (up to 5 years)
Social Determinants of Health: Lifestyle & Environment Survey
Results of surveys that collect information about social determinants of health.
Measured: Baseline and every 6 months until study end (up to 5 years)
Family Health History in Health Conditions and Health Events
Results of self-reported family health history of first-degree biologic family.
Measured: Baseline and have option to update if needed (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start12 Feb 2025
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Apple Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital, MCRA
- Responsible party
- Principal investigator, Calum A. MacRae, Brigham and Women's Hospital
- Investigators
- Calum MacRae, MD, PhD, Principal investigator, Brigham and Women's HospitalTiffany Avery, MD, Principal investigator, MCRA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958523
- Sponsor's protocol ID
- Pro00081895
- Other IDs
- 2024P003608
- Status last verified
- Jul 2025
- First submitted
- 5 Mar 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apple Health Study
- ClinicalTrials.gov ID
- NCT06958523
- Acronym / sponsor ID
- Pro00081895
- Conditions
- Mental Health, Sleep, Exercise, Hormones, Metabolic Health, Hearing
- Keywords
- Apple Health Study, Large Scale Digital Study, Digital Biomarkers, Research App, Apple Research App, iPhone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- Apple Inc.Industry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital, MCRA
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Apple Health Study aims to build a diverse and inclusive group of participants to help researchers advance our understanding of how signals and information collected from apps and devices relate to health and may be used to predict, detect, monitor, and manage changes in health.
To enroll, US residents who have an iPhone can download the Apple Research app from the App Store and go through the introduction and informed consent for the Apple Health Study. This study is fully remote, and all are invited to enroll if the eligibility criteria are met.
Participants will be asked to complete tasks and surveys, using their iPhone and Apple Research app which include:
- Selecting the types of data they would like to share with the study such as health and sensor data
- Completing tasks and surveys including areas such as personal demographic information, personal medical history, family history, and social determinants of health
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Study aims to enroll a large and representative group of at least 500,000 participants across the United States of America willing to contribute information about health and wellness over time.
Key inclusion criteria (6 listed)
- Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico);
- Live in the United States of America;
- Have an iPhone;
- Have installed Apple Research app on your iPhone;
- Be comfortable communicating in written and spoken English;
Key exclusion criteria (1 listed)
- Share your iCloud account, iPhone, or devices that collect health data such as Apple Watch with anyone else, because it could result in sharing another person's health information with the Study, making it challenging for researchers to use your information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health Status
Time frame: Baseline and every 6 months until study end (up to 5 years)
Assessed by participant self-report as well as clinical health records and claims data. The initial count and change over time in the number and type of health conditions such as cardiovascular, circulatory, cognition, hearing, mental health, metabolic, mobility, neurologic, respiratory, sex and gender, reproduction, hormones, sleep, and health events such as hospitalizations, procedures or falls.
3 secondary outcomes
Participant Population: Demographic Characteristics of Study Participants
Time frame: Baseline and annually until study end (up to 5 years)
Social Determinants of Health: Lifestyle & Environment Survey
Time frame: Baseline and every 6 months until study end (up to 5 years)
Family Health History in Health Conditions and Health Events
Time frame: Baseline and have option to update if needed (up to 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Apple Health Study WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Calum MacRae, MD, PhD principal investigator
Brigham and Women's Hospital
Tiffany Avery, MD principal investigator
MCRA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Sleep, run by Apple Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MCRA Study Call Center (833-600-6993, applehealthstudy@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Status (time frame: Baseline and every 6 months until study end (up to 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.