Gulf War Illness Nasal Irrigation Study (NCT01700725) | Clinical Trial Compass
CompletedPhase 2
Gulf War Illness Nasal Irrigation Study
United States40 participantsStarted 2012-10
Plain-language summary
The purpose of this study is to determine whether nasal irrigation with Xylitol or saline are effective in the treatment of chronic rhinosinusitis and fatigue symptoms associated with Gulf War Illness.
Who can participate
Age range35 Years – 75 Years
SexALL
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Inclusion Criteria:
* English fluency and basic reading and writing literacy.
* Deployment to the Persian Gulf (e.g., Iraq, Kuwait, Saudi Arabia) for the purpose of Operation Desert Shield or Operation Desert Storm during the first Gulf War (1990-1991).
* Meeting criteria for a diagnosis of GWI as based on the "Kansas" GWI case definition; only the Kansas case definition (from among the several currently used case definitions) can differentiate between Gulf War-deployed and non-deployed Gulf era veterans.
* Meeting criteria for a diagnosis of chronic rhinosinusitis (CRS) using self-reported symptoms and based on clinical guidelines; eligible subjects will report: • sinonasal symptoms for at least 12 weeks; • a constellation of sinonasal symptoms including either two or more major factors, or 1 major and 2 minor factors (see Table 1 below), or chronic nasal purulence for 12 or more weeks; and • a moderate to severe HRQoL impact (≥ 3 points on a 0-10 Likert severity scale) as assessed by a single item question:11 "What has been the average level of your sinus symptoms daily over the past month on a 0-10 scale?" This item is consistent with eligibility criteria used in prior NI studies.
* Chronic fatigue of moderate-to-severe severity defined as scoring at least 3 points on a single question (0-10 Likert scale): "What has been the average level of your daily fatigue over the past month on a 0-10 scale?"
Exclusion Criteria:
* Self-reported pregnancy.
* Current use of liquid NI…
What they're measuring
1
Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline
Timeframe: Change from baseline week 8, change from baseline week 26