Fatigue Clinical Trial
Official title:
Nasal Irrigation for Chronic Rhinosinusitis and Fatigue in Patients With Gulf War Illness
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.
Background: Gulf War Illness (GWI) results in tremendous impact to quality of life. Symptoms
of chronic rhinosinusitis (CRS) and fatigue are the first (47%) and third (41%) most common
symptoms of patients with GWI, respectively. These symptoms are biologically characterized by
a milieu of elevated levels of proinflammatory cytokines; to date, the profile of these
cytokines in serum and nasal secretions is incompletely understood and has not been assessed
in response to therapy. Nasal irrigation (NI) is a therapy which bathes the nasal cavity with
a solution (liquid). There are two promising forms of NI; saline NI (S-NI) is hypothesized to
improve sinus symptoms by thinning and clearing mucus and inflammatory mediators, decreasing
mucosal edema and improving ciliary function. Xylitol NI (X-NI) has been shown to change the
salinity of the mucosal surface resulting in enhanced antimicrobial properties. Although NI
is an evidence-based adjunctive therapy for CRS and has been reported to be effective for CRS
and fatigue, it has not been assessed in a GWI population.
Specific Aims, Hypotheses and Study Design: The specific aims of this proposal are to
determine whether routine care plus S-NI, or X-NI, compared to routine care alone, result in
improved health-related quality of life (HRQoL), are cost-effective and decrease
proinflammatory bias in subjects with GWI who suffer from CRS and fatigue.
Consistent with our specific aims, we will test the following hypotheses: In an RCT setting,
at 26 weeks post-enrollment, adults with GWI and symptoms of CRI and fatigue, treated with
routine care plus S-NI or X-NI, compared to those treated with routine care alone, will
demonstrate:
H1: improved HRQoL: a) sinus-disease specific HRQoL as evaluated by the validated Sinonasal
Outcomes Test (SNOT-20) questionnaire (primary outcome measure); b) fatigue-specific HRQoL as
assessed by the validated questionnaire, the Multidimensional Fatigue Inventory (MFI); and c)
overall HRQoL as assessed by the validated questionnaire the Medical Outcomes Survey Short
Form-36 (SF-36; mental and physical health domains) augmented with 18 sleep- and breathing
related questions.
H.2: greater cost-effectiveness as measured by the average cost of the intervention divided
by the average effectiveness (as assessed by a improvement in SNOT-20 scores), and reported
as the "dollars spent per subject restored to health."
H.3: improved treatment satisfaction as assessed by a single-item treatment satisfaction
score and a qualitative exit interview.
H.4: improved proinflammatory bias: a) reduced activation and dysregulation of
proinflammatory pathways as determined by a reduction in URI-specific inflammatory cytokines
in serum and nasal secretions; and b) improved serum-based complete blood count,
sedimentation rate or C-reactive protein, or nasal swab-based neutrophil or eosinophil
counts.
Study Design: 26 week duration of follow-up, 3-arm RCT (N=75). All groups will utilize
routine care for their GWI and symptoms of CRS and fatigue. Groups 1 and 2 will in addition
add S-NI or X-NI twice daily to their routine care, respectively. Group 3 will continue to
use routine care with no other additions (control group); control group participants will be
offered NI training and related materials (xylitol or saline per subject preference) after
they complete their 26-week follow-up period.
Impact: Positive findings would suggest a number of important effects:
- Statistically positive results on HRQoL outcome measures would suggest that NI can
provide effective adjunctive therapy for CRS and fatigue in adults with GWI, improving
health of affected patients and potentially providing gains to society through reduced
health care utilization and absenteeism related costs.
- Positive biomarker findings would contribute to our better understanding of the etiology
of CRS and fatigue in the GWI population and of possible biological pathways underlying
the NI efficacy.
- The finding that either form of NI is cost effective would provide economic
justification for its clinical use.
;
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