Mobile Health Monitoring for Military Service Well-Being

Enrolling by invitation at 1 trial location

Overseen By Trevor Barrett, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Pre or post operational environment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app and Apple Watch to monitor the mental and physical health of US Military Special Operation Forces (SOF). It aims to determine if these tools can reduce stress and improve performance by tracking heart rate, activity, and sleep over six months. The study targets Army and Marine Warfighters preparing for deployment or recently returned from deployment. Participants should not be in situations that prevent adherence to the study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance military personnel's well-being.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the study coordinators for guidance.

What prior data suggests that this mobile health monitoring method is safe for military service members?

Research shows that the Apple Watch is generally safe and includes many safety features. It monitors health information like heart rate and offers emergency functions such as fall and crash detection. These features aim to keep users safe.

Regarding the study app, early research indicates that similar digital health apps are popular among military members. Designed to boost well-being and resilience, these apps have been tested in previous studies and received high marks for effectiveness.

Both the Apple Watch and the study app aim to support users without causing harm. They collect data and offer helpful features while prioritizing user safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Apple Watch and a Study App for military service well-being because these tools offer a unique way to monitor health continuously and remotely. Unlike traditional methods that rely on periodic check-ups, this approach provides real-time data, potentially identifying issues before they become serious. The convenience and non-invasiveness of wearable technology make it an appealing option for military personnel who may have limited access to regular healthcare facilities. Additionally, the use of a dedicated app allows for personalized feedback and interventions, which could enhance overall well-being by addressing individual needs more effectively.

What evidence suggests that this app and sensor intervention is effective for monitoring military service well-being?

Research shows that the Apple Watch aids health care by tracking, reminding, and predicting health outcomes. It collects data such as heart rate and activity levels, which are important for understanding mental and physical health. Additionally, digital health apps have benefited military members by reducing mental health issues and boosting resilience. Studies have found these apps effectively provide health information and support to service members. In this trial, all participants will use both the Apple Watch and the study app, which together offer promising tools to monitor and potentially enhance the well-being of military personnel. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for US Military Special Operation Forces who are post-deployment within three months or pre-deployment within six months. It's specifically for members of the 3rd SFG(A) and 1st Reconnaissance Battalion. Those unable to follow the study due to operational environments will be excluded.

Inclusion Criteria

Post or Pre-deployment Army and Marine Warfighters in 3rd SFG(A) and 1st Reconnaissance Battalion.

Post-deployment (defined as within three months of returning from deployment) for 3rd SFG(A) and within six months prior to deployment for 1st Reconnaissance Battalion

Exclusion Criteria

I am not planning any surgeries that would interfere with the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Deployment Monitoring

Participants are monitored using a mobile app and wearable sensors to collect continuous data on physical, neurocognitive, psychological, and lifestyle factors

Up to 6 months

Continuous monitoring via app and sensors

Post-Deployment Monitoring

Continued monitoring of participants using the mobile app and wearable sensors to assess mental and physical status

Approximately 6 months

Continuous monitoring via app and sensors

Follow-up

Participants are monitored for safety and effectiveness after the main monitoring period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Apple Watch
• Study App

Trial Overview The study tests a mobile app and Apple Watch in monitoring mental and physical status over six months, aiming to support warfighters by potentially reducing degradation and optimizing performance through continuous data collection.

How Is the Trial Designed?

Group I: App/Sensor Intervention Experimental Treatment 1 Intervention

All subjects will be enrolled into the same experimental group for the duration of the study

Apple Watch is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as Apple Watch for:

• General wellness monitoring
• Heart rate monitoring
• Sleep tracking

Approved in European Union as Apple Watch for:

• General wellness monitoring
• Heart rate monitoring
• Sleep tracking
• ECG monitoring

Approved in Canada as Apple Watch for:

• General wellness monitoring
• Heart rate monitoring
• Sleep tracking

Approved in Japan as Apple Watch for:

• General wellness monitoring
• Heart rate monitoring
• Sleep tracking

Approved in China as Apple Watch for:

• General wellness monitoring
• Heart rate monitoring
• Sleep tracking

Approved in Switzerland as Apple Watch for:

• General wellness monitoring
• Heart rate monitoring
• Sleep tracking

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9494213/

The Apple Watch for Monitoring Mental Health–Related ... This literature review aims to identify current and potential physiological or physiologically related monitoring capabilities of the Apple Watch relevant to ...

2. apple.com apple.com/watch/compare/?modelList=watch-series-7,watch-series-6

Apple Watch Compare Compare specs for the latest Apple Watch models: Apple Watch Ultra 3, Apple Watch Series 11, and Apple Watch SE 3.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11549588/

The Value of Smartwatches in the Health Care Sector for ... We propose a categorization of smartwatch use in the health care sector into 3 key functional domains: monitoring, nudging, and predicting.

4. apple.com apple.com/healthcare/

Healthcare Apple Watch collects a huge amount of healthcare data that enables us to research and study the relationship of health outcomes to lifestyle ...

5. support.apple.com support.apple.com/en-us/111848

Apple Watch Series 8 - Technical Specifications Features: Water resistant, Blood oxygen sensor, Electrical heart sensor, High-g accelerometer, Display: 45mm, 41mm, Always-On Retina LTPO OLED display.

6. apple.com apple.com/watch/compare/

Apple Watch Compare Compare specs for the latest Apple Watch models: Apple Watch Ultra 3, Apple Watch Series 11, and Apple Watch SE 3.

7. support.apple.com support.apple.com/guide/watch/apple-watch-models-apd2054d0d5b/watchos

Apple Watch models Welcome to Apple Watch, the versatile wrist-worn companion that can help motivate you to be more active, track important health information, stay in touch with ...

8. support.apple.com support.apple.com/guide/watch/safety-features-apd95ec0adc6/watchos

Safety features on Apple Watch Safety features on Apple Watch · Check In · Medical ID · Contact emergency services · Fall Detection · Crash Detection · Siren · Communicate via satellite · Apple ...