Assessing Improvement in Cognitive Deficit in CRS in Patients Treated With Medical Vs Surgical Management

NCT04291118 | Unknown

• 1 other identifier: H19-03659
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic rhinosinusitis presents with a plethora of symptoms including non-rhinologic symptoms such as depression, sleep disturbances \& the more recently recognized cognitive dysfunction. It has recently been identified that sinus specific treatments such as endoscopic sinus surgery can improve cognitive outcomes in patients with cognitive deficit secondary to chronic inflammation in the upper and lower airway. However, it remains to be seen whether or not offering surgery to these patients at an earlier date has an impact on the degree of improvement on cognitive function in comparison to patients who have to wait long periods for their treatment.

Conditions

Chronic Sinusitis

Keywords

Endoscopic Sinus Surgery; Medical Management; Cognitive Dysfunction; Modified Mini Mental State Examination

Outcome Measures

Primary Outcomes (1)

• Change in Modified mini mental state examination

  This short test consists of questions to assess memory which will take 5-10 minutes to complete.

  Before starting medical or surgical management and then 6 months after

Secondary Outcomes (3)

• Change in Cognitive failures Questionnaire

  Before starting medical or surgical management and then 6 months after

• Change in Sino-nasal Outcome Test-22 (SNOT-22) scores:

  Before starting medical or surgical management and then 6 months after

• Change in Nasal endoscopy

  Before starting medical or surgical management and then 6 months after

Study Arms (3)

Medical Management and Sinus Surgery in private system

OTHER

These patients will first receive medical management for their symptoms and then will undergo sinus surgery much earlier than the other group as they will include patients being operated in the private system.

Procedure: Private system endoscopic sinus surgery

Medical Management and Sinus Surgery in public system

OTHER

These patients will first receive medical management for their symptoms, and then will undergo sinus surgery after a waiting period of at least 1 year since they are on the public wait-list.

Procedure: Public system endoscopic sinus surgery

Medical Management Only

OTHER

These patients will only receive medical management for their symptoms as they will not require sinus surgery.

Drug: Budesonide

Interventions

Private system endoscopic sinus surgery PROCEDURE

Patients that will undergo endoscopic sinus surgery though the private system. Beforehand they could of used medical management including, budesonide for their symptoms.

Medical Management and Sinus Surgery in private system

Public system endoscopic sinus surgery PROCEDURE

Patients that undergo endoscopic sinus surgery though the public system after waiting for at least 1 year. Beforehand they could of used medical management, including budesonide for their symptoms.

Medical Management and Sinus Surgery in public system

Budesonide DRUG

Patients will receive medical management for their symptoms that will consist of topical nasal steroid, budesonide and any other required medication for their disease.

Medical Management Only

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with CRS (with/without polyps) and are willing to undergo medical management with antibiotics or steroids, and/or surgical management with functional endoscopic sinus surgery if required

You may not qualify if:

• Patients currently having sinonasal tumors - as the middle turbinate may have to be resected in certain cases
• Has undergone functional endoscopic sinus surgery
• Patients with autoimmune diseases affecting the upper airway (e.g. systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, etc.)
• Are immuno-compromised, and have impairment in mucociliary function (e.g. cystic fibrosis, Kartagener syndrome)

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (1)

E.N.T. Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Athena Pascual

CONTACT

604-806-9926; apascual@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: New patients diagnosed with CRS (with or without polyps) who will receive medical or/and surgical management will be recruited for the study. They will be separated into one of 3 study arms based on the clinical care they require.

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 2, 2020
• Study Start: February 10, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 2, 2020

Record last verified: 2020-02

Locations

CA (1)