Gulf War Illness Nasal Irrigation Study (GWINIS)
|ClinicalTrials.gov Identifier: NCT01700725|
Recruitment Status : Active, not recruiting
First Posted : October 4, 2012
Last Update Posted : May 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Persian Gulf Syndrome Chronic Sinusitis Fatigue Acute Sinusitis||Other: Nasal Irrigation - Saline Drug: Nasal Irrigation - Xylitol||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700725
|United States, Wisconsin|
|University of Wisconsin General Clinical Research Center|
|Madison, Wisconsin, United States, 53792|
|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|