Overview

Gulf War Illness Nasal Irrigation Study

Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Wisconsin, Madison
Treatments:
Pharmaceutical Solutions
Criteria
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 or xylitol nasal spray; regular use is defined as 1 or more
irrigations weekly for 3 consecutive weeks.

- Self-reported neurological or musculoskeletal conditions that could facilitate
aspiration, or patients who otherwise cannot physically perform the NI procedure.

- Self-reported borderline personality disorder.

- Inability or stated reluctance to reliably participate in study activities.

- Severe or unstable mental health problems that would preclude safe or reliable study
participation as based on an in-person evaluation by a psychiatry team; active
delusional disorder, depressive disorder or alcohol/drug abuse or dependence will be a
primary target of this interview using both a structured clinical interview (MINI ref)
and psychiatry team evaluation.