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Gulf War Illness Nasal Irrigation Study (GWINIS)

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ClinicalTrials.gov Identifier: NCT01700725
Recruitment Status : Unknown
Verified May 2016 by University of Wisconsin, Madison.
Recruitment status was:  Active, not recruiting
First Posted : October 4, 2012
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Persian Gulf Syndrome Chronic Sinusitis Fatigue Acute Sinusitis Other: Nasal Irrigation - Saline Drug: Nasal Irrigation - Xylitol Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasal Irrigation for Chronic Rhinosinusitis and Fatigue in Patients With Gulf War Illness
Study Start Date : October 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
Drug Information available for: Xylitol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nasal Irrigation - Saline
nasal irrigation using saline plus routine care for symptoms of CRS and fatigue
 Other: Nasal Irrigation - Saline
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.
Other Name: 2% buffered saline
Experimental: Nasal Irrigation - Xylitol
Nasal Irrigation with Xylitol plus routine care for symptoms of CRS and fatigue
 Drug: Nasal Irrigation - Xylitol
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.
Other Name: 5% Xylitol solution
No Intervention: Control Group
Control group subjects continue to use routine care only


Outcome Measures
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Primary Outcome Measures :
  1. Sino-Nasal Outcome Test (SNOT-20) questionnaire [ Time Frame: Baseline, change from baseline week 8, change from baseline week 26 ]
    Sino-Nasal Outcome Test (SNOT-20) is a recommended tool for clinical trial research involving CRS. Sinus disease specific quality of life will be measured using the total score of this validated 20 item questionnaire. It is a reliable and valid outcome measure for patients with CRS (Cronbach's α 0.9, test-retest r = 0.9)that describes the health burden and is sensitive to clinical change. Patients who are more affected by CRS tend to have greater SNOT-20 scores (P < 0.01). The SNOT-20 score is expected to improve in NI-treated subjects compared to controls. Findings of the PI's prior RCT of adults with CRS are consistent with the above evidence.


Secondary Outcome Measures :
  1. Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline and weeks 8 & 26 ]
    The Multidimensional Fatigue Inventory is a validated disease specific outcome measure for fatigue. The instrument has good internal consistency (average Cronbach's alpha 0.84). Construct validity was established after comparisons between and within groups, assuming differences in fatigue based on differences in circumstances and/or activity level. Convergent validity was investigated by correlating the MFI-scales with a Visual Analogue Scale measuring fatigue. Fatigue is expected to improve in the NI-treated patients compared to controls.

  2. Medical Outcomes Survey Short Form-36 (SF-36) [ Time Frame: Baseline and weeks 8 & 26 ]
    SF-36 is a validated questionnaire designed to assess health status, function and overall health related quality of life. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The SF-36 has Cronbach's alphas ranging from 0.69 to 0.95, and discriminant validity 98-100%. Gulf War Illness and chronic rhinosinusitis both affect sleep and breathing parameters. Prior studies suggest that both may be improved with SNI in some subjects. We have added eighteen relevant sleep and breathing related questions to the SF-36.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700725


Locations
United States, Wisconsin
University of Wisconsin General Clinical Research Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Rachel Molander, MD US Department of Veterans Affairs, William S. Middleton Memorial Veterans Hospital
Principal Investigator: David P Rabago, MD University of Wisconsin, Madison
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01700725     History of Changes
Other Study ID Numbers: GW100054 US Dept of Defense
2011-0843 ( Other Identifier: HS IRB )
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016

Keywords provided by University of Wisconsin, Madison:
Gulf War Illness
xylitol
nasal irrigation
Desert Storm
Persian Gulf Conflicts
neti pot
 cytokines
nasal mucus
inflammatory mediator
lactoferrin
lysozyme

Additional relevant MeSH terms:
Fatigue
Sinusitis
Persian Gulf Syndrome
Signs and Symptoms
Paranasal Sinus Diseases
Nose Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Occupational Diseases
Pharmaceutical Solutions