Non-smokersNCT01039935
Genetic Basis of Odor Discrimination
An observational study of Non-smokers, run by Rockefeller University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-smokers
- How many people
- 512 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Age 18-50
- Current non-smokers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
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.
- Conditions
- Non-smokers
- Keywords
- Odor Discrimination
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (1)
concentration at which odors need to be added to allow for discrimination; thresholds to all six odors; verbal descriptors assigned to all six odors
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-smokersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Vosshall, PhD, Principal investigator, The Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039935
- Sponsor's protocol ID
- LVO-0684
- Status last verified
- Sep 2012
- First submitted
- 23 Dec 2009
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Basis of Odor Discrimination
- ClinicalTrials.gov ID
- NCT01039935
- Acronym / sponsor ID
- LVO-0684
- Conditions
- Non-smokers
- Keywords
- Odor Discrimination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- Age 18-50
- Current non-smokers
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Vosshall, PhD principal investigator
The Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-smokers, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.