Persian Gulf SyndromeNCT00007514
Investigate Olfactory Functioning as a Possible Proxy for Neurotoxic Exposure in Cohorts of Deployed and Non-Deployed Gulf War-Era Veterans.
An observational study of Persian Gulf Syndrome and Occupational Exposure, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Significant subsets of military veterans have reported such health problems as headache, joint pain, fatigue, and memory/concentration difficulties subsequent to their participation in the Gulf War. However, the etiology remains controversial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Persian Gulf Syndrome, Occupational Exposure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Feb 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Deployed and nondeployed GW-era veterans.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vamc - New Orleans, La
New Orleans, Louisiana, 70112
About this study
Official title: Olfactory Functioning in Gulf War Veterans
Significant subsets of military veterans have reported such health problems as headache, joint pain, fatigue, and memory/concentration difficulties subsequent to their participation in the Gulf War. However, the etiology remains controversial. A number of toxins have been implicated as etiologic factors for GW-related health problems; however, exposure levels have been difficult, if not impossible, to document retrospectively. These difficulties with exposure verification have led GW researchers to de-emphasize methods typical of neurotoxicological research examining exposure-symptom relationships and instead focus on epidemiological approaches emphasizing identification of coherent symptom patterns.
Read the detailed description
Primary Objectives: 1) To investigate olfactory functioning as a possible proxy for neurotoxic exposure in cohorts of deployed and non-deployed Gulf War-era veterans; and, 2) To examine potential associations between olfactory functioning and neurocognitive performance on measures known to be sensitive to neurotoxic sequelae.
Secondary Objectives: To examine associations between olfactory functioning and stress-related psychopathology, namely posttraumatic stress disorder, in Gulf War (GW) veterans.
Primary Outcomes: The aim of this proposal is to investigate olfactory functioning in cohorts of deployed and non-deployed GW-era veterans. In searching for symptom patterns related to neurotoxic exposure, examination of deployment status and neurocognitive dysfunction in relation to a sensory measure (i.e., olfaction) sensitive to environmental toxins has the potential to contribute additional confirming or disconfirming evidence of GW exposures.
Intervention: N/A
Study Abstract: This study is funded by the Durham ERIC's Pilot Studies Initiative and is being conducted by researchers at the New Orleans, LA VAMC.
Significant subsets of military veterans have reported such health problems as headache, joint pain, fatigue, and memory/concentration difficulties subsequent to their participation in the Gulf War. However, the etiology remains controversial. A number of toxins have been implicated as etiologic factors for GW-related health problems; however, exposure levels have been difficult, if not impossible, to document retrospectively. These difficulties with exposure verification have led GW researchers to de-emphasize methods typical of neurotoxicological research examining exposure-symptom relationships and instead focus on epidemiological approaches emphasizing identification of coherent symptom patterns.
The proposed research builds on a Merit Review Award to Dr. Vasterling, "Follow-up of Psychological and Neurocognitive Gulf War Outcome: Relation to Stress," which is a longitudinal, case-controlled study of psychological functioning in over 800 deployed and 250 nondeployed GW-era veterans. Variables currently examined include self-reported health symptoms, psychological symptoms, and individual difference variables (e.g., personality characteristics), stress exposure, self-reported environmental hazards exposures, and objective neurocognitive data (on a subset of veterans). This pilot study extends the "Follow-up" study by introducing a distinct set of variables related to olfactory functioning.
The study design of the pilot study is case-controlled. A projected 120 male and female GW veterans who were deployed to the war zone and 38 male and female military personnel activated during the Gulf War will participate. Olfactory measures include olfactory identification, and odor intensity and pleasantness judgments, which have been revealed by factor analysis to reflect distinct olfactory components. Odors are presented using the University of Pennsylvania Smell Identification Test. A brief neurocognitive battery including standardized, age-normed measures of functions sensitive to neurotoxic exposure (i.e., attention, fine motor skills, executive functioning, and memory) are also administered. Psychopathology and self-reported health measures are also administered as part of the larger "Follow-up" study.
To-date, 32 deployed and 12 nondeployed veterans have been enrolled in the study. Subject accrual and data collection are ongoing. The sample size is currently too small to detect meaningful trends. It is expected that this pilot work will generate a manuscript submitted to a peer-reviewed scientific journal and development of a full-scale epidemiological grant proposal.
- Conditions
- Persian Gulf Syndrome, Occupational Exposure
- Keywords
- olfactory functioning, neurotoxic exposure, Gulf War-era veterans
- Medical subject headings
- Persian Gulf Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2001 (estimated)
- Study startMar 2000
- Study completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persian Gulf SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007514
- Sponsor's protocol ID
- 723D
- Status last verified
- Feb 2003
- First submitted
- 29 Dec 2000
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Functioning in Gulf War Veterans
- ClinicalTrials.gov ID
- NCT00007514
- Acronym / sponsor ID
- 723D
- Conditions
- Persian Gulf Syndrome, Occupational Exposure
- Keywords
- olfactory functioning, neurotoxic exposure, Gulf War-era veterans
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2000
- Study completion
- Feb 2001
- First posted
- 1 Jan 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Significant subsets of military veterans have reported such health problems as headache, joint pain, fatigue, and memory/concentration difficulties subsequent to their participation in the Gulf War. However, the etiology remains controversial. A number of toxins have been implicated as etiologic factors for GW-related health problems; however, exposure levels have been difficult, if not impossible, to document retrospectively. These difficulties with exposure verification have led GW researchers to de-emphasize methods typical of neurotoxicological research examining exposure-symptom relationships and instead focus on epidemiological approaches emphasizing identification of coherent symptom patterns.
Detailed description
Primary Objectives: 1) To investigate olfactory functioning as a possible proxy for neurotoxic exposure in cohorts of deployed and non-deployed Gulf War-era veterans; and, 2) To examine potential associations between olfactory functioning and neurocognitive performance on measures known to be sensitive to neurotoxic sequelae.
Secondary Objectives: To examine associations between olfactory functioning and stress-related psychopathology, namely posttraumatic stress disorder, in Gulf War (GW) veterans.
Primary Outcomes: The aim of this proposal is to investigate olfactory functioning in cohorts of deployed and non-deployed GW-era veterans. In searching for symptom patterns related to neurotoxic exposure, examination of deployment status and neurocognitive dysfunction in relation to a sensory measure (i.e., olfaction) sensitive to environmental toxins has the potential to contribute additional confirming or disconfirming evidence of GW exposures.
Intervention: N/A
Study Abstract: This study is funded by the Durham ERIC's Pilot Studies Initiative and is being conducted by researchers at the New Orleans, LA VAMC.
Significant subsets of military veterans have reported such health problems as headache, joint pain, fatigue, and memory/concentration difficulties subsequent to their participation in the Gulf War. However, the etiology remains controversial. A number of toxins have been implicated as etiologic factors for GW-related health problems; however, exposure levels have been difficult, if not impossible, to document retrospectively. These difficulties with exposure verification have led GW researchers to de-emphasize methods typical of neurotoxicological research examining exposure-symptom relationships and instead focus on epidemiological approaches emphasizing identification of coherent symptom patterns.
The proposed research builds on a Merit Review Award to Dr. Vasterling, "Follow-up of Psychological and Neurocognitive Gulf War Outcome: Relation to Stress," which is a longitudinal, case-controlled study of psychological functioning in over 800 deployed and 250 nondeployed GW-era veterans. Variables currently examined include self-reported health symptoms, psychological symptoms, and individual difference variables (e.g., personality characteristics), stress exposure, self-reported environmental hazards exposures, and objective neurocognitive data (on a subset of veterans). This pilot study extends the "Follow-up" study by introducing a distinct set of variables related to olfactory functioning.
The study design of the pilot study is case-controlled. A projected 120 male and female GW veterans who were deployed to the war zone and 38 male and female military personnel activated during the Gulf War will participate. Olfactory measures include olfactory identification, and odor intensity and pleasantness judgments, which have been revealed by factor analysis to reflect distinct olfactory components. Odors are presented using the University of Pennsylvania Smell Identification Test. A brief neurocognitive battery including standardized, age-normed measures of functions sensitive to neurotoxic exposure (i.e., attention, fine motor skills, executive functioning, and memory) are also administered. Psychopathology and self-reported health measures are also administered as part of the larger "Follow-up" study.
To-date, 32 deployed and 12 nondeployed veterans have been enrolled in the study. Subject accrual and data collection are ongoing. The sample size is currently too small to detect meaningful trends. It is expected that this pilot work will generate a manuscript submitted to a peer-reviewed scientific journal and development of a full-scale epidemiological grant proposal.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persian Gulf Syndrome and Occupational Exposure, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2009.