Trial · NCT01700725
Gulf War Illness Nasal Irrigation Study
NCT01700725, Phase 2, Completed, University of Wisconsin, Madison; results first posted 2019-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gulf War Illness Nasal Irrigation Study. Trials, record NCT01700725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01700725
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gulf War Illness Nasal Irrigation Study
- NCT number
- NCT01700725
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- University of Wisconsin, Madison
- Conditions
- Persian Gulf Syndrome, Chronic Sinusitis, Fatigue, Acute Sinusitis
- Interventions
- Nasal Irrigation - Saline, Nasal Irrigation - Xylitol
- First posted
- 2012-10-04
- Last updated
- 2019-05-21
- Results first posted
- 2019-05-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Sino-Nasal Outcome Test (SNOT-20) Score From 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. The total range of possible scores is 0-100. The higher the score, the worse the symptoms. |
| Secondary | Change in Multidimensional Fatigue Inventory (MFI) Over Baseline | Baseline to 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. The total range of possible scores is 0-100. The higher the score, the more fatigue. |
| Secondary | Change in Medical Outcomes Survey Short Form-36 (SF-36) Over Baseline | 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. 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline | Change from baseline week 8, change from baseline week 26 | Data from one participant in the control group and two participants in the Saline group at 26 weeks was unable to be collected. | score on a scale | MEAN |
| SECONDARY | Change in Multidimensional Fatigue Inventory (MFI) Over Baseline | Baseline to weeks 8 & 26 | Data from several participants was unable to be collected at various timepoints. | score on a scale | MEAN |
| SECONDARY | Change in Medical Outcomes Survey Short Form-36 (SF-36) Over Baseline | Baseline and weeks 8 & 26 | Data from one participant at 26 weeks in the control group was unable to be collected. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline | Nasal Irrigation - Xylitol | Baseline to Week 8 | -16.9 | Standard Deviation 4.9 | score on a scale |
| Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline | Nasal Irrigation - Saline | Baseline to Week 8 | -8.8 | Standard Deviation 5.0 | score on a scale |
| Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline | Control Group | Baseline to Week 8 | -3.4 | Standard Deviation 5.3 | score on a scale |
| Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline | Nasal Irrigation - Xylitol | Baseline to Week 26 | -18.9 | Standard Deviation 4.9 | score on a scale |
| Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline | Nasal Irrigation - Saline | Baseline to Week 26 | -16.9 | Standard Deviation 5.3 | score on a scale |
| Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline | Control Group | Baseline to Week 26 | -3.5 | Standard Deviation 5.6 | score on a scale |
| Change in Multidimensional Fatigue Inventory (MFI) Over Baseline | Nasal Irrigation - Xylitol | Baseline to Week 8 | 0.6 | Standard Deviation 2.4 | score on a scale |
| Change in Multidimensional Fatigue Inventory (MFI) Over Baseline | Nasal Irrigation - Saline | Baseline to Week 8 | 0.9 | Standard Deviation 2.3 | score on a scale |
| Change in Multidimensional Fatigue Inventory (MFI) Over Baseline | Control Group | Baseline to Week 8 | 0.5 | Standard Deviation 2.5 | score on a scale |
| Change in Multidimensional Fatigue Inventory (MFI) Over Baseline | Nasal Irrigation - Xylitol | Baseline to Week 26 | 1.9 | Standard Deviation 2.8 | score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nasal Irrigation - Xylitol | 14 | |
| Overall Study | STARTED | Nasal Irrigation - Saline | 14 | |
| Overall Study | STARTED | Control Group | 12 | |
| Overall Study | COMPLETED | Nasal Irrigation - Xylitol | 14 | |
| Overall Study | COMPLETED | Nasal Irrigation - Saline | 14 | |
| Overall Study | COMPLETED | Control Group | 12 | |
| Overall Study | NOT COMPLETED | Nasal Irrigation - Xylitol | 0 | |
| Overall Study | NOT COMPLETED | Nasal Irrigation - Saline | 0 | |
| Overall Study | NOT COMPLETED | Control Group | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nasal Irrigation - Xylitol | 0 | 14 |
| Total, all-cause mortality | Nasal Irrigation - Saline | 0 | 14 |
| Total, all-cause mortality | Control Group | 0 | 12 |
| Total, other adverse events | Nasal Irrigation - Xylitol | 0 | 14 |
| Total, other adverse events | Nasal Irrigation - Saline | 0 | 14 |
| Total, other adverse events | Control Group | 0 | 12 |
| Total, serious adverse events | Nasal Irrigation - Xylitol | 0 | 14 |
| Total, serious adverse events | Nasal Irrigation - Saline | 0 | 14 |
| Total, serious adverse events | Control Group | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25625809 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01700725
GET https://conductscience.org/api/trials/v1/NCT01700725/registered