Gulf War Illness Nasal Irrigation Study
Condition: Persian Gulf Syndrome; Chronic Sinusitis; Fatigue; Acute Sinusitis
MeSH terms: Sinusitis; Fatigue; Persian Gulf Syndrome
Intervention: Nasal Irrigation - Saline; Nasal Irrigation - Xylitol
Intervention description: Liquid-based nasal irrigation (NI) is performed using a nasal irrigation cup ("neti pot"), a simple hand-held vessel that uses the force of gravity to gently irrigate the user's nasal cavity. Subjects will be requested to perform NI twice daily. The subjects will prepare the saline solution by themselves using the study-provided kit which will include packets of salt powder and the neti pot; subjects will dissolve the powder in lukewarm tap water to achieve a 2% buffered saline solution. The solution is then delivered to the nasal cavity using neti pot.; Liquid-based nasal irrigation (NI) is performed using a nasal irrigation cup ("neti pot"), a simple hand-held vessel that uses the force of gravity to gently irrigate the user's nasal cavity. Subjects will be requested to perform NI twice daily. The subjects will prepare the Xylitol solution by themselves using the study-provided kit which will include packets of Xylitol powder and the neti pot; subjects will dissolve the powder in lukewarm tap water to achieve a 5% Xylitol solution. The solution is then delivered to the nasal cavity using neti pot.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Gulf War Illness; xylitol; nasal irrigation; Desert Storm; Persian Gulf Conflicts; neti pot; cytokines; nasal mucus; inflammatory mediator; lactoferrin; lysozyme

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.
    

Eligibility 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.