Legionnaires' Effect on Smell

Legionnaires' Disease Clinical Trial

Official title:

Legionella Pneumonia's Effect on Olfactory Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03321786
• Other study ID #: 827730
• Status: Recruiting
• Start date: September 6, 2017
• Est. completion date: October 2024

Study information

• Verified date: June 2023
• Source: University of Pennsylvania
• Contact: Richard L Doty, PhD
• Phone: 215-662-6580
• Email: richard.doty[@]uphs.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2024
• Est. primary completion date: May 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Legionellosis
• Legionnaires' Disease

Intervention

Other:
• The University of Pennsylvania Smell Identification Test (UPSIT)
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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the University of Pennsylvania Smell Identification Test	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	Questionnaire Responses	These are various demographic and medical history questions regarding exposure to Legionella Pneumonia and current experiences post diagnosis and treatment.	20-30 Minutes