Hayer Supriya D, Rabago David P, Amaza Iliya P, Kille Tony, Coe Christopher L, Zgierska Aleksandra, Zakletskaia Larissa, Mundt Marlon P, Krahn Dean, Obasi Chidi N, Molander Rachel C
1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
Contemp Clin Trials. 2015 Mar;41:219-26. doi: 10.1016/j.cct.2015.01.008. Epub 2015 Jan 24.
Gulf War Illness (GWI) affects 1 in 7 returned Persian Gulf War veterans. Quality-of-life impact is large; there is no cure. Chronic sinus symptoms and fatigue are common. Nasal irrigation with saline (NI-S) or xylitol (NI-X) improve sinus symptoms and fatigue in the general population. This trial will assess the effect of NI-S and NI-X on sinus and fatigue symptoms, economic outcomes and pro-inflammatory milieu among participants with GWI.
75 participants (age 35 to 65 years, 25 in each of three arms) with GWI will be recruited from the Veteran's Administration and the community. They will use routine care for sinus symptoms and fatigue and be randomized to continued usual care alone or additional therapy with NI-S or NI-X. Participants will be able to adjust specific elements of the NI procedure. The primary outcome (Sinonasal Outcome Test, SNOT-20) and other self-reported assessments will occur at baseline, 8 and 26 weeks; lab assessment of pro-inflammatory cellular and cytokine profiles will occur at baseline and 26 weeks. Other outcomes will include fatigue-specific and overall health-related quality of life, pro-inflammatory cellular and cytokine profiles, cost-effectiveness and participant satisfaction.
Baseline demographic and clinical data from the first 10 participants show effective participant recruitment, enrollment, randomization, retention and data collection.
Early study conduct suggests that our participant-oriented approach will yield high rates of participant adherence and data capture, facilitating robust analysis. Results of this study will clarify the value of NI for chronic sinus symptoms and fatigue among patients with GWI.
clinicaltrials.gov identifier NCT01700725.
海湾战争综合症（GWI）影响着七分之一的海湾战争退伍军人。对生活质量的影响很大；目前尚无治愈方法。慢性鼻窦症状和疲劳很常见。用生理盐水（NI-S）或木糖醇（NI-X）进行鼻腔冲洗可改善普通人群的鼻窦症状和疲劳。本试验将评估NI-S和NI-X对GWI参与者的鼻窦和疲劳症状、经济结果及促炎环境的影响。
将从退伍军人管理局和社区招募75名年龄在35至65岁之间的GWI参与者（三个组每组25人）。他们将接受鼻窦症状和疲劳的常规治疗，并随机分为仅继续接受常规治疗或额外接受NI-S或NI-X治疗。参与者将能够调整NI程序的具体内容。主要结局（鼻窦结局测试，SNOT-20）和其他自我报告评估将在基线、8周和26周时进行；促炎细胞和细胞因子谱的实验室评估将在基线和26周时进行。其他结局将包括特定于疲劳的和与整体健康相关的生活质量、促炎细胞和细胞因子谱、成本效益及参与者满意度。
前10名参与者的基线人口统计学和临床数据表明，参与者招募、入组、随机分组、留存和数据收集有效。
早期研究开展情况表明，我们以参与者为导向的方法将产生较高的参与者依从率和数据捕获率，便于进行有力的分析。本研究结果将阐明NI对GWI患者慢性鼻窦症状和疲劳的价值。
clinicaltrials.gov标识符NCT01700725。
