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OpenTrials
Enrolling by Invitation

NCT Number: NCT02825654

Service and Health Among Deployed Veterans

The purpose of the study is to better understand the health, including lung health, of Veterans who deployed in support of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), or Operation New Dawn (OND) and other deployments following these Operations.

Enrolling by Invitation

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

VA San Diego Healthcare System, San Diego, CA, San Diego, California, United States

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About this study

The aim of the study is to characterize the impact of deployment-related pollution exposures during the Post-9/11 Gulf War Era on current respiratory health using objectively ascertained and standardized physiologic and epidemiologic measures. The primary objective in support of this aim is to assess the association of cumulative exposure to PM2.5 during deployments to the U.S. bases and other locations in Central Asia (Afghanistan and Kyrgyzstan), Southwest Asia (Iraq, Kuwait, Qatar, and United Arab Emirates) and Africa (Djibouti) with current measures of pulmonary function. Secondary objectives in support of the aim will examine the association of cumulative exposure to PM2.5 during deployments with the clinical outcome of medically-treated asthma. The investigators will also explore the impact of deployment duration on both pulmonary function and asthma.

This study will execute 4 distinct efforts to meet the study objectives: (1) enroll a study cohort of up to 6,200 Veterans who live within the catchment area of 6 VA recruitment sites, conduct an in-person assessment of pulmonary function, and collect data on key covariates; (2) create a spatial-temporal exposure grid of environmental PM2.5 levels averaged per week per 1 square kilometer at locations where military personnel served; (3) link each individual's location and duration (spatial-temporal) history during deployed and non-deployed times with averaged PM exposures during each of these time periods; and (4) conduct association analyses to test hypotheses of deployment-related cumulative PM2.5 exposure and current respiratory health by combining exposure data with data collected from the cohort members and from their military records.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Served during the Post-9/11 Gulf War Era in a service branch that had land-based deployments (Air Force, Army, and Marine Corps)
  • Deployed to Afghanistan, Kyrgyzstan, Iraq, Kuwait, Qatar, United Arab Emirates, or Djibouti between October 1, 2001 and August 31, 2021

Exclusion criteria

  • Active duty at the time of recruitment
  • Impaired decision making capacity
  • No English language proficiency
  • Prisoners

Treatment and study plan

Primary outcomes

  1. Current forced expiratory volume in 1 second (FEV1)

    Time frame: Outcome measured at time of in-person study visit (Day 1)

    An assessment of pulmonary function obtained through spirometry

Secondary outcomes

  1. Current forced vital capacity (FVC)

    Time frame: Outcome measured at time of in-person study visit (Day 1)

    An assessment of pulmonary function obtained through spirometry

  2. Current FEV1/FVC ratio

    Time frame: Outcome measured at time of in-person study visit (Day 1)

    An assessment of pulmonary function obtained through spirometry

  3. Pharmaceutically-treated asthma

    Time frame: Outcome measured at time of in-person study visit (Day 1)

    Based on medication inventory, the investigators will classify medically-treated asthma therapy into mild, moderate, and severe based on the intensity of asthma therapy as suggested by the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2015.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Harvard University
  • United States Department of Defense

Registry information

Official study title

CSP #595 - Pulmonary Health and Deployment to Southwest Asia and Afghanistan

Acronym: SHADE

Important dates

Study start
2018
Primary completion
2027
Study completion
2029
First posted
Jul 7, 2016
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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