Legionnaires' Effect on Smell
July 23, 2024 updated by: Richard Doty, University of Pennsylvania
Legionella Pneumonia's Effect on Olfactory Function
The goal of this study is to determine whether survivors of Legionnaires' disease suffer smell loss.
A quantitative olfactory test will be performed by the participants.
Such testing will require approximately 20-30 minutes of the participant's time.
The participants will take the University of Pennsylvania Smell Identification Test (UPSIT), a scratch-and-sniff test to assess their ability to identify odors in a forced- choice format.
Volunteers will also complete a questionnaire asking personal history, demographic questions, and medical history.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- UNIVERSITY of PENNSYLVANIA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
The subjects to be tested in this study represent two different populations.
The first is a group of who have survived Legionnaires' disease.
The second group will be healthy men and women over the age of 18 years.
Description
Inclusion Criteria:
- Persons of generally good health, as obtained from a screening questionnaire who are 18 years of age and older
- Both men and women of all ethnic backgrounds will be accepted.
Exclusion Criteria:
- Age less than 18
- Pregnant Women
- Persons who mental competence is limited, such as those with dementia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Legionnaires' Disease Volunteers
Volunteers who have been diagnosed/survivors of Legionnaire's Disease
|
This standardized test, the most widely used olfactory test in the world, is derived from basic psychological test measurement theory and focuses on the comparative ability of subjects to identify odorants at the suprathreshold level.
The UPSIT consists of four envelope-sized booklets, each containing ten "scratch and sniff" odorants embedded in 10- 50-µm polymer microcapsules positioned on brown strips at the bottom of the pages of the booklets.
|
|
Healthy Volunteers
Volunteers who are healthy.
|
This standardized test, the most widely used olfactory test in the world, is derived from basic psychological test measurement theory and focuses on the comparative ability of subjects to identify odorants at the suprathreshold level.
The UPSIT consists of four envelope-sized booklets, each containing ten "scratch and sniff" odorants embedded in 10- 50-µm polymer microcapsules positioned on brown strips at the bottom of the pages of the booklets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Score on the University of Pennsylvania Smell Identification Test
Time Frame: 20-30 Minutes
|
The number of correct odor identification responses out of 40 from the standardized University of Pennsylvania Smell Identification Test. The total number of correct responses will then be compared to standard norms of correct responses based on demographic information such as age and sex. Comparing the scores to the standard norms collected will indicate whether a volunteer is normosmic, hyposmic, or anosmic. |
20-30 Minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire Responses
Time Frame: 20-30 Minutes
|
These are various demographic and medical history questions regarding exposure to Legionella Pneumonia and current experiences post diagnosis and treatment.
|
20-30 Minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard L Doty, PhD, UNIVERSITY of PENNSYLVANIA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2017
Primary Completion (Actual)
June 15, 2024
Study Completion (Actual)
June 15, 2024
Study Registration Dates
First Submitted
October 23, 2017
First Submitted That Met QC Criteria
October 23, 2017
First Posted (Actual)
October 26, 2017
Study Record Updates
Last Update Posted (Actual)
July 24, 2024
Last Update Submitted That Met QC Criteria
July 23, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 827730
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.