CClinicalTrials.gg
CompletedNCT03321786Updated Jul 24, 2024

Legionnaires' Effect on Smell

An observational study in Legionnaires' Disease, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Legionnaires' Disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Age less than 18
  • Pregnant Women
  • Persons who mental competence is limited, such as those with dementia
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherThe 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.

05

What researchers measure

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.

    Time frame: 20-30 Minutes

Secondary outcomes

  1. Questionnaire Responses

    These are various demographic and medical history questions regarding exposure to Legionella Pneumonia and current experiences post diagnosis and treatment.

    Time frame: 20-30 Minutes

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Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
07

Registry details

Key details

Study ID
NCT03321786
Lead sponsor
University of Pennsylvania
Responsible party
Richard Doty (Director, Smell and Taste Center, Professor of Psychology in Otorhinolaryngology: Head and Neck Surgery, University of Pennsylvania) — Principal investigator
First posted
Oct 26, 2017
Start date
Sep 6, 2017
Primary completion
Jun 15, 2024
Completion
Jun 15, 2024
Last update
Jul 24, 2024

Study contacts

Richard L Doty, PhD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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