Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007514
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2000-12-29
Brief Title:
Investigate Olfactory Functioning as a Possible Proxy for Neurotoxic Exposure in Cohorts of Deployed and Non-Deployed Gulf War-Era Veterans
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Olfactory Functioning in Gulf War Veterans
Status:
COMPLETED
Status Verified Date:
2003-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Significant subsets of military veterans have reported such health problems as headache joint pain fatigue and memoryconcentration 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 ie olfaction sensitive to environmental toxins has the potential to contribute additional confirming or disconfirming evidence of GW exposures
Intervention NA
Study Abstract This study is funded by the Durham ERICs 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 memoryconcentration 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 eg 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 ie 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
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 ie olfaction sensitive to environmental toxins has the potential to contribute additional confirming or disconfirming evidence of GW exposures
Intervention NA
Study Abstract This study is funded by the Durham ERICs 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 memoryconcentration 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 eg 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 ie 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: