Legionnaires' Effect on Smell

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: Recruiting
• Conditions: Legionnaires' Disease
• Intervention / Treatment: Other: The University of Pennsylvania Smell Identification Test (UPSIT)

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Richard L Doty, PhD; Phone Number: 215-662-6580; Email: richard.doty@uphs.upenn.edu
• Study Contact Backup: Name: Rafa Khan, BA; Phone Number: 610-390-0805; Email: khanr@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Richard L Doty, PhD

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Legionnaires' Disease Volunteers; Volunteers who have been diagnosed/survivors of Legionnaire's Disease	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.
Healthy Volunteers; Volunteers who are healthy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Richard L Doty, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2017
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): October 1, 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): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Legionnaires' Disease; Legionellosis
• 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