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Service and Health Among Deployed Veterans

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02825654
Acronym
SHADE
Enrollment
6200
Registered
2016-07-07
Start date
2018-03-08
Completion date
2029-06-30
Last updated
2025-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Function

Keywords

Pulmonary, Lung, Military and environmental exposures, Epidemiologic, Observational, Interview or questionnaire, Deployment related, Enduring Freedom, Iraqi Freedom

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

United States Department of Defense
CollaboratorFED
Harvard University
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Current forced expiratory volume in 1 second (FEV1)Outcome measured at time of in-person study visit (Day 1)An assessment of pulmonary function obtained through spirometry

Secondary

MeasureTime frameDescription
Current forced vital capacity (FVC)Outcome measured at time of in-person study visit (Day 1)An assessment of pulmonary function obtained through spirometry
Current FEV1/FVC ratioOutcome measured at time of in-person study visit (Day 1)An assessment of pulmonary function obtained through spirometry
Pharmaceutically-treated asthmaOutcome 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026