- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01039935
Genetic Basis of Odor Discrimination
September 5, 2012 updated by: Rockefeller University
Prior to the main study we will perform a pilot study on 60 subjects.
The purpose of the pilot study is to identify the range of odor concentrations that will be used in the main study and to optimize the tasks performed in the main study.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
512
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
-
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New York
-
New York, New York, United States, 10065
- The Rockefeller University
-
-
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 to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy volunteers
Description
Inclusion Criteria:
- Age 18-50
- Current non-smokers
Exclusion Criteria:
- Current smokers
- Allergy to fragrances or smells of any kind
- Active head cold, upper respiratory infection, or seasonal nasal allergies
- History of nasal health problems, including endoscopic nasal surgery for sinus conditions or polyp removal.
- Pre-existing medical condition that has caused anosmia or near total loss of the sense of smell, such as: head injury, cancer therapy, radiation to head and neck, or alcoholism
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of correct responses when discriminating between (-)-carvone and (+)-carvone, isovaleric acid and isobutyric acid, androstenone and androstadienone DNA sequence of ORs sensitive to these odors
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
concentration at which odors need to be added to allow for discrimination; thresholds to all six odors; verbal descriptors assigned to all six odors
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leslie Vosshall, PhD, The Rockefeller University
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
November 1, 2009
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
December 23, 2009
First Submitted That Met QC Criteria
December 24, 2009
First Posted (Estimate)
December 25, 2009
Study Record Updates
Last Update Posted (Estimate)
September 6, 2012
Last Update Submitted That Met QC Criteria
September 5, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LVO-0684
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.
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