Chronic SinusitisNCT04291118
Assessing Improvement in Cognitive Deficit in CRS in Patients Treated With Medical Vs Surgical Management
A study testing Private system endoscopic sinus surgery, Public system endoscopic sinus surgery and Budesonide in people with Chronic Sinusitis, run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial summary
Chronic rhinosinusitis presents with a plethora of symptoms including non-rhinologic symptoms such as depression, sleep disturbances \& the more recently recognized cognitive dysfunction. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Private system endoscopic sinus surgery, Public system endoscopic sinus surgery and Budesonide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
E.N.T. Clinic, St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Athenea Pascual, PHD, 6048069926, apascual@providencehealth.bc.ca
Amin R Javer, MD,FRCSC,FARS
About this study
Official title: A Comparative Study Assessing Improvement in Cognitive Deficit Secondary to CRS in Patients Treated With Medical Vs Surgical Management: A Prospective Trial
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.
Read the detailed description
Purpose To compare the improvement in cognitive deficit after medical management and surgical management in the treatment of Chronic Rhinosinusitis.
Hypothesis Cognitive deficit secondary to chronic rhinosinusitis will show a greater improvement with surgical management when compared to medical management.
Cognitive deficit secondary to chronic rhinosinusitis will improve quicker postoperatively for patients offered endoscopic sinus surgery earlier than for those who are placed on long waitlists for surgery
Study Design:
This is a prospective cohort series to be conducted at the St. Paul's Sinus Centre. All patients recruited into the study would have been diagnosed with chronic rhinosinusitis and will be subjected to appropriate and standardized medical management. They will be subjected to surgical management if they are not completely relieved of their symptoms. Prior to medical or surgical management, they will be subjected to the modified mini mental state examination to assess their baseline and post treatment (medical and surgical) cognitive function.
Data storage and safeguards The data will be stored on a password protected computer at St. Paul's Hospital in the Department of Otolaryngology on an encrypted Microsoft excel spreadsheet. The computer containing study data will be password-protected for access only by the principal investigator, co-investigator and study coordinator stored in a locked office, and backed-up remotely on to a secured hospital server. All hard copy documents will be kept in binders, in the Principal Investigator's office in a locked cabinet.
Patients participating in the study will all be assigned random study ID numbers. The study code is not derived from or related to the information about the individual, i.e., name, SIN, PHN, hospital number, DOB, address, or unique characteristic. These numbers will be used on all study documentation. Participant names are being stored separately from study data in a master list with the study ID numbers.
Data Monitoring Patients will continue to be assessed at routine follow up visits. Statistics will be completed after the study is complete on its objectives. Data will be also monitored on a continuous basis.
Statistical Analysis
Descriptive statistics will be used to summarize all demographic data, comorbidities, and adverse effects reported by the patients. Paired student t-tests will be applied to investigate the difference between the mean 3M Examination scores, MLK scores, SNOT-22 scores, before commencement of each treatment arm and subsequent MLK scores, SNOT-22 scores after treatment is complete. A running total of the treatment costs for each patient will be maintained. One way Anova test will be applied to investigate the difference between the mean costs for each treatment arm. Probability values less than 0.05 will be considered statistically significant.
- Conditions
- Chronic Sinusitis
- Being tested
- Private system endoscopic sinus surgery, Public system endoscopic sinus surgery, Budesonide
- Keywords
- Endoscopic Sinus Surgery, Medical Management, Cognitive Dysfunction, Modified Mini Mental State Examination
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Private system endoscopic sinus surgeryProcedure or surgery
Patients that will undergo endoscopic sinus surgery though the private system. Beforehand they could of used medical management including, budesonide for their symptoms.
Public system endoscopic sinus surgeryProcedure or surgery
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.
BudesonideDrug
Patients will receive medical management for their symptoms that will consist of topical nasal steroid, budesonide and any other required medication for their disease.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified mini mental state examination
This short test consists of questions to assess memory which will take 5-10 minutes to complete.
Measured: Before starting medical or surgical management and then 6 months after
Secondary outcomes (3)
Change in Cognitive failures Questionnaire
This includes 25 questions for patients to self-report everyday errors of perception, memory and motor functioning. It is scored out of 100 with higher score indicating worse more cognitive failures.
Measured: Before starting medical or surgical management and then 6 months after
Change in Sino-nasal Outcome Test-22 (SNOT-22) scores:
This is a standard of care form that includes 22 questions about symptoms and social/emotional consequences of participants nasal disorder. Participants will be asked to rate their problems based on the past two weeks. The questionnaire is out of 110 points with higher score indicating worse symptoms.
Measured: Before starting medical or surgical management and then 6 months after
Change in Nasal endoscopy
This is standard-of-care at St. Paul's Sinus Centre. Participants sinuses will be examined using an instrument called an endoscope which is a metal rod with a camera attached at the end. During the sinus examination, pictures and scores of the sinuses will be recorded. Endoscopic score are given from 0-2 based on endoscopic evidence of polyps, edema and discharge. A higher score indicates worse symptoms.
Measured: Before starting medical or surgical management and then 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start10 Feb 2020
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Javer, St. Paul's Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291118
- Sponsor's protocol ID
- H19-03659
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Assessing Improvement in Cognitive Deficit Secondary to CRS in Patients Treated With Medical Vs Surgical Management: A Prospective Trial
- ClinicalTrials.gov ID
- NCT04291118
- Acronym / sponsor ID
- H19-03659
- Conditions
- Chronic Sinusitis
- Keywords
- Endoscopic Sinus Surgery, Medical Management, Cognitive Dysfunction, Modified Mini Mental State Examination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose To compare the improvement in cognitive deficit after medical management and surgical management in the treatment of Chronic Rhinosinusitis.
Hypothesis Cognitive deficit secondary to chronic rhinosinusitis will show a greater improvement with surgical management when compared to medical management.
Cognitive deficit secondary to chronic rhinosinusitis will improve quicker postoperatively for patients offered endoscopic sinus surgery earlier than for those who are placed on long waitlists for surgery
Study Design:
This is a prospective cohort series to be conducted at the St. Paul's Sinus Centre. All patients recruited into the study would have been diagnosed with chronic rhinosinusitis and will be subjected to appropriate and standardized medical management. They will be subjected to surgical management if they are not completely relieved of their symptoms. Prior to medical or surgical management, they will be subjected to the modified mini mental state examination to assess their baseline and post treatment (medical and surgical) cognitive function.
Data storage and safeguards The data will be stored on a password protected computer at St. Paul's Hospital in the Department of Otolaryngology on an encrypted Microsoft excel spreadsheet. The computer containing study data will be password-protected for access only by the principal investigator, co-investigator and study coordinator stored in a locked office, and backed-up remotely on to a secured hospital server. All hard copy documents will be kept in binders, in the Principal Investigator's office in a locked cabinet.
Patients participating in the study will all be assigned random study ID numbers. The study code is not derived from or related to the information about the individual, i.e., name, SIN, PHN, hospital number, DOB, address, or unique characteristic. These numbers will be used on all study documentation. Participant names are being stored separately from study data in a master list with the study ID numbers.
Data Monitoring Patients will continue to be assessed at routine follow up visits. Statistics will be completed after the study is complete on its objectives. Data will be also monitored on a continuous basis.
Statistical Analysis
Descriptive statistics will be used to summarize all demographic data, comorbidities, and adverse effects reported by the patients. Paired student t-tests will be applied to investigate the difference between the mean 3M Examination scores, MLK scores, SNOT-22 scores, before commencement of each treatment arm and subsequent MLK scores, SNOT-22 scores after treatment is complete. A running total of the treatment costs for each patient will be maintained. One way Anova test will be applied to investigate the difference between the mean costs for each treatment arm. Probability values less than 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medical Management and Sinus Surgery in private system | Other | Procedure: Private system endoscopic sinus surgeryThese 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. |
| Medical Management and Sinus Surgery in public system | Other | Procedure: Public system endoscopic sinus surgeryThese 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. |
| Medical Management Only | Other | Drug: BudesonideThese patients will only receive medical management for their symptoms as they will not require sinus surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Private system endoscopic sinus surgeryPatients that will undergo endoscopic sinus surgery though the private system. Beforehand they could of used medical management including, budesonide for their symptoms. | Procedure or surgery | Medical Management and Sinus Surgery in private system |
| Public system endoscopic sinus surgeryPatients 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. | Procedure or surgery | Medical Management and Sinus Surgery in public system |
| BudesonidePatients will receive medical management for their symptoms that will consist of topical nasal steroid, budesonide and any other required medication for their disease. | Drug | Medical Management Only |
Primary outcome
Change in Modified mini mental state examination
Time frame: Before starting medical or surgical management and then 6 months after
This short test consists of questions to assess memory which will take 5-10 minutes to complete.
3 secondary outcomes
Change in Cognitive failures Questionnaire
Time frame: Before starting medical or surgical management and then 6 months after
Change in Sino-nasal Outcome Test-22 (SNOT-22) scores:
Time frame: Before starting medical or surgical management and then 6 months after
Change in Nasal endoscopy
Time frame: Before starting medical or surgical management and then 6 months after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Private system endoscopic sinus surgery, Public system endoscopic sinus surgery and Budesonide in people with Chronic Sinusitis, run by St. Paul's Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Athena Pascual (604-806-9926, apascual@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified mini mental state examination (time frame: Before starting medical or surgical management and then 6 months after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.