Genetic Basis of Odor Discrimination | NCT01039935

Studies
Genetic Basis of Odor Discrimination

NCT01039935

Sponsor

Rockefeller University

Status

Completed

Last Update Posted

Sep 6, 2012Estimated

Enrollment

512Actual

Phase

Not provided

Conditions

Non-smokers

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Dec 23, 2009

First Submission Date that Met QC Criteria

Dec 24, 2009

First Posted Date

Dec 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2012

Last Update Posted Date

Sep 6, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

512Actual

Outcomes Module

Primary Outcomes

Measure	Description	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		3 years

Secondary Outcomes

Measure	Description	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		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Healthy volunteers

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leslie Vosshall, PhD	The Rockefeller University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Rockefeller University		New York	New York	10065	United States