NCT01001039

Brief Summary

This study proposes to develop and validate a new instrument designed to measure facial and nasal discomfort related to chronic sinusitis. The second phase of the study will be to use this instrument to measure correlation with sinus computed tomography (CT) scans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 29, 2012

Status Verified

June 1, 2012

Enrollment Period

1.7 years

First QC Date

October 21, 2009

Last Update Submit

June 27, 2012

Conditions

Sinusitis

Keywords

chronic sinusitisfacial pain

Study Arms (2)

control

Patients seen in the Otology clinic who have not had sinus surgery in the past 2 months or a history of sinusitis in the last 6 months.

cases

Patients seen in the Rhinology Clinic with a complaint of facial pain. They must have evidence of chronic sinusitis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting to the Rhinology Clinic with a complaint of facial pain and evidence of chronic sinusitis. Control subjects will be patients presenting to the Otology Clinic with no evidence of sinusitis.

You may qualify if:

  • Case subjects from the Rhinology Clinic must have CT evidence of chronic sinusitis
  • Control subject from the Otology Clinic who have not had sinus surgery in the past 2 months

You may not qualify if:

  • any subject unable to give informed consent of complete self-administered questionnaires written in English
  • Control subjects with a history of sinusitis in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Rhinology Clinic

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

SinusitisFacial Pain

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Greg E Davis, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 23, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2011

Study Completion

June 1, 2012

Last Updated

June 29, 2012

Record last verified: 2012-06

Locations

US(1)