Service and Health Among Deployed Veterans

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Current forced expiratory volume in 1 second (FEV1) [Срок оценки: Outcome measured at time of in-person study visit (Day 1)]

Вторичные конечные точки (3)

• Current forced vital capacity (FVC) [Срок оценки: Outcome measured at time of in-person study visit (Day 1)]
• Current FEV1/FVC ratio [Срок оценки: Outcome measured at time of in-person study visit (Day 1)]
• Pharmaceutically-treated asthma [Срок оценки: Outcome measured at time of in-person study visit (Day 1)]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 6 центров

• VA San Diego Healthcare System, San Diego, CA — San Diego
• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur
• VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA — West Roxbury
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston
• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle

Публикации

• Garshick E, Redlich CA, Korpak A, Timmons AK, Smith NL, Nakayama K, Baird CP, Ciminera P, Kheradmand F, Fan VS, Hart JE, Koutrakis P, Kuschner W, Ioachimescu O, Jerrett M, Montgrain PR, Proctor SP, Wan ES, Wendt CH, Wongtrakool C, Blanc PD. Chronic respiratory symptoms following deployment-related occupational and environmental exposures among US veterans. Occup Environ Med. 2024 Feb 2;81(2):59-65 PMID 37968126
• Maccarone JR, Sterns OR, Timmons A, Korpak AM, Smith NL, Nakayama KS, Baird CP, Ciminera P, Kheradmand F, Fan VS, Hart JE, Koutrakis P, Jerrett M, Kuschner WG, Ioachimescu OC, Montgrain PR, Proctor SP, Redlich CA, Wendt CH, Blanc PD, Garshick E, Wan ES. Deployment-related Cigarette Smoking Behaviors and Pulmonary Function Among U.S. Veterans. Mil Med. 2024 Aug 30;189(9-10):2030-2038. doi: 10.1093/ PMID 38536226
• Maccarone J, Redlich CA, Timmons A, Korpak AM, Smith NL, Nakayama KS, Baird CP, Ciminera P, Kheradmand F, Fan VS, Hart JE, Koutrakis P, Kuschner WG, Ioachimescu OC, Jerrett M, Montgrain PR, Proctor SP, Wendt CH, Wongtrakool C, Wan ES, Blanc PD, Garshick E. Sinusitis and rhinitis among US veterans deployed to Southwest Asia and Afghanistan after September 11, 2001. J Allergy Clin Immunol Glob. 2024 PMID 39659739
• Hosseini R, Garshick E, Slade MD, Timmons A, Korpak AM, Smith NL, Nakayama KS, Baird CP, Ciminera P, Kheradmand F, Fan VS, Hart JE, Koutrakis P, Kuschner WG, Ioachimescu OC, Jerrett M, Montgrain PR, Proctor SP, Wendt CH, Wongtrakool C, Wan ES, Blanc PD, Redlich CA. Military Inhalational Exposures Outside the Theater of Conflict and Chronic Respiratory Symptoms. JAMA Netw Open. 2025 Jul 1;8(7):e252 PMID 40690216

Идентификаторы

NCT: NCT02825654 · 595

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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