Legionnaires' Effect on Smell

NCT03321786 | Completed

• 1 other identifier: 827730
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Legionnaires' Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Questionnaire Responses

  20-30 Minutes

Study Arms (2)

Legionnaires' Disease Volunteers

Volunteers who have been diagnosed/survivors of Legionnaire's Disease

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

Healthy Volunteers

Volunteers who are healthy.

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

Interventions

The University of Pennsylvania Smell Identification Test (UPSIT) OTHER

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; Legionnaires' Disease Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Age less than 18
• Pregnant Women
• Persons who mental competence is limited, such as those with dementia

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Legionnaires' Disease

Condition Hierarchy (Ancestors)

Legionellosis; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Richard L Doty, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Smell and Taste Center, Professor of Psychology in Otorhinolaryngology: Head and Neck Surgery

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 26, 2017
• Study Start: September 6, 2017
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

US (1)