Mobile Health Monitoring for Military Service Well-Being

Recruiting 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

500 Participants Needed

Trial Summary

What is the purpose of this trial?

In this study, we aim to continuously and comprehensively measure the mental and physical status of US Military Special Operation Forces (SOF) through a confidential and cybersecure research mobile application (app) over a six-month period. In conjunction with data collected via the mobile app, wearable sensors, such as the Apple Watch, will be used to continuously collect physiologic (e.g. heart rate) and other data (e.g. activity, sleep). Additionally, the app will have the capability of delivering helpful features, such as information and activities to ideally support study subjects, mitigate degradation, and optimize performance. The overall objective of the proposal is to investigate whether the app can contribute to reducing overall warfighter degradation and if degradation can be predicted from daily continuous measures of physical and mental behavior.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+