Fatigue Clinical Trial
— GWINISOfficial title:
Nasal Irrigation for Chronic Rhinosinusitis and Fatigue in Patients With Gulf War Illness
Verified date | May 2019 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2017 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin General Clinical Research Center | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline | 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 a 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. The total range of possible scores is 0-100. The higher the score, the worse the symptoms. | Change from baseline week 8, change from baseline week 26 | |
Secondary | Change in Multidimensional Fatigue Inventory (MFI) Over Baseline | 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. The total range of possible scores is 0-100. The higher the score, the more fatigue. | Baseline to weeks 8 & 26 | |
Secondary | Change in Medical Outcomes Survey Short Form-36 (SF-36) Over Baseline | 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. 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. Eighteen relevant sleep and breathing related questions to the SF-36. The total range is 0-100. The lower the score, the more disability. | Baseline and weeks 8 & 26 |
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