NCT01039935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 25, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 6, 2012

Status Verified

September 1, 2012

Enrollment Period

2.8 years

First QC Date

December 23, 2009

Last Update Submit

September 5, 2012

Conditions

Non-smokers

Keywords

Odor Discrimination

Outcome Measures

Primary Outcomes (1)

  • 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 (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

    3 years

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Age 18-50
  • Current non-smokers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample taken

Study Officials

  • Leslie Vosshall, PhD

    The Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2009

First Posted

December 25, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

September 6, 2012

Record last verified: 2012-09

Locations

US(1)