Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis

April 19, 2022 updated by: Dr. Timothy L. Smith, Oregon Health and Science University
Olfactory dysfunction is a cardinal symptom of chronic rhinosinusitis, a disease which affects 12.5% of the adult population across all racial and ethnic groups. Previous research has documented olfactory deficit in 68% of patients with chronic rhinosinusitis and 20% with complete anosmia, suggesting that olfactory dysfunction affects over 25 million individuals in the United States with chronic rhinosinusitis. This proposed investigation will be used to predict olfactory outcomes following treatments for chronic rhinosinusitis and gain insights into mechanisms of olfactory dysfunction in this population.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

418

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 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who present in clinic with indications of medically refractory chronic sinusitis.

Description

Inclusion Criteria:

  • Adult ( > 18 years of age)
  • A diagnosis of medical recalcitrant CRS as defined by 2015 Adult Sinusitis Guidelines outlined by the American Academy of Otolaryngology
  • Provide written informed consent and authorization.
  • Study participants must be able to complete consent, all study evaluations, olfactory testing, and study-related health questionnaires written in the English language.
  • Patients must self-select subsequent treatment option (endoscopic sinus surgery or continued medical therapy) to be dictated by the disease process and judgment and preferences of each individual, following counseling for each treatment option.
  • Present to the enrolling site with indication for a CT scan or a CT scan completed, off-site, from another provider
  • Complete appropriate standardized medical treatment by the Interim Assessment, 6-week follow-up period including, but not limited to, at least one course of either topical corticosteroids (>21-days) or a 5-day course of oral corticosteroid therapy, and at least one course (>14-days) of culture-directed or broad spectrum antibiotic therapy.

Exclusion Criteria:

  • Children (< 18 years of age)
  • Any patient unable and/or unwilling to complete questionnaires or clinical testing or cooperate with all study protocols.
  • Non-English speaking / English translation services required
  • Unwilling or unable to provide informed, written consent.
  • Contra-indications for any type of continued medical therapy required for treatment of symptoms related to CRS
  • Patients who have not undergone previous prescribed medical therapy as described in Inclusion Criteria.
  • Individuals of any vulnerable population including: children, pregnant women, neonates, decisionally impaired adults, or prisoners.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Appropriate Medical Therapy
Patients will self-select continued, non-standardized, appropriate medical management of symptoms associated with chronic sinusitis.
Endoscopic Sinus Surgery
Patients will self-select endoscopic sinus surgery for symptoms associated with chronic sinusitis.
Procedure: Endoscopic sinus surgery
Other Names:
  • Sinus surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sniffin' Stick olfactory testing
Time Frame: 6 months
Improvement in olfactory function
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
22-Item Sinonasal Outcome Test
Time Frame: 6 months
Improvement in disease specific quality of life
6 months
Questionnaire for Olfactory Dysfunction, QOD-NS
Time Frame: 6 months
Improvement in olfactory specific quality of life
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 1, 2016

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (Estimate)

March 28, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC005805-11

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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