Clinical Trial TitleCognitive Impairment in Chronic Rhinosinusitis
Clinical Trial Protocol Description:
Cognitive impairment is characterized by problems with memory, language, thinking, or judgment. Despite the tremendous known impact of impaired cognition on quality of life and individuals’ health, besides our pilot study; impaired cognitive function associated with sleep timing disruption as its potential mechanisms has not been objectively investigated in patients with inflammatory and allergic respiratory diseases such as chronic rhinosinusitis (CRS). Our KL-2 supported studies and preliminary data have shown significant cognitive impairment in CRS patients compared to controls that were associated with sleep disturbance and sleep timing changes.
The overall objectives of this proposed study are to:
- Characterize cognitive function profile in both healthy controls and patients with chronic inflammation in upper airways; and identify those at risk of impaired cognition
- Identify the preventable risk factors of cognitive impairment including sleep timing shift
- Test the hypothesis that serum IL-6 has a role in this process and may serve as a biomarker for cognitive impairment in CRS
The purpose of this study is to understand and describe the problems associated with memory, language, thinking, or judgment in patients with chronic sinus disease which is long lasting symptoms of nasal congestion and inflammation in the sinuses.
What is involved for a participant in the study:
- 6 Questionnaires
- Cognitive Assessments (~ 30 minutes)
- Wear Actigraphy for 7 days/nights (a small fitbit like watch)
- Blood sample collections (~1-2 tablespoons of blood collected by the Rush University Medical Center Laboratory to understand inflammation proteins in the blood)
Duration of the study: The study will last up to 6 months. Ideally, participants complete all tasks within 2 weeks.
Compensation: Participants will be paid up to $50 cash for completion of all study tasks ($10 for questionnaires, $10 for cognitive assessments, $10 for actigraphy, $20 for blood sample).
Clinical Trial Eligibility Criteria:
We will recruit healthy control patients will be recruited from three sources:
- The Rush Allergy clinic
- Rush ENT clinic
- The general patient population of Rush University Medical Center.
Control patients without CRS or respiratory symptoms will be targeted for inclusion from the general Rush University Medical Center population.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.