Sleep Disturbance and Daytime Fatigue as Predictors of Cognitive Decline and Functional Decline in Chronic Rhinosinusitis
NCT ID: NCT07242040
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
134 participants
OBSERVATIONAL
2024-09-15
2025-09-25
Brief Summary
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Detailed Description
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Chronic rhinosinusitis (CRS) is a prevalent inflammatory condition associated with significant impairment in quality of life. While sinonasal symptoms are well-documented, systemic manifestations such as sleep disturbance, fatigue, and cognitive decline are underexplored. Emerging evidence suggests that sleep and energy dysregulation may independently contribute to cognitive dysfunction and physical debilitation in chronic inflammatory diseases. However, limited research has quantified these associations specifically in CRS.
Objective:
The FOCUS-CRS study (Fatigue and cOgnitive Comorbidities of chrOnic rSinosUS) investigates whether sleep disturbance and daytime fatigue are significant predictors of cognitive and functional decline in adults with CRS. The study also explores the role of demographic and clinical factors such as age, gender, duration of symptoms, and comorbid conditions in moderating these relationships.
Methods:
This is a single-center, cross-sectional observational study involving 134 CRS patients recruited from outpatient clinics. Participants completed validated questionnaires measuring sleep disturbance, daytime fatigue, and domain-specific quality of life (QoL), including physical functioning (QoL-physical) and cognitive/mental health (QoL-mental). Spearman correlations and multivariate linear regression were performed to assess the predictive effects of sleep and fatigue scores on QoL outcomes, controlling for potential confounders.
Expected Impact:
The findings from this study will enhance clinical awareness of sleep and fatigue-related comorbidities in CRS and support the development of integrative care models. Early identification and management of sleep and fatigue symptoms may contribute to improved cognitive and functional outcomes in CRS patients.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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CRS Patients Group
All participants were adults diagnosed with chronic rhinosinusitis (CRS). This group underwent standardized, non-interventional assessments to evaluate the association between sleep disturbance, daytime fatigue, and quality of life outcomes. No experimental treatment or diagnostic procedures were administered as part of the study.
Self-Reported Questionnaires for Sleep, Fatigue, and Quality of Life
Participants completed a set of validated self-report instruments to assess:
Sleep disturbance (Likert-type scale)
Daytime fatigue (Likert-type scale)
Quality of life - physical and mental domains
No clinical intervention was introduced. Data were analyzed using correlation and regression models to determine predictive associations.
Interventions
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Self-Reported Questionnaires for Sleep, Fatigue, and Quality of Life
Participants completed a set of validated self-report instruments to assess:
Sleep disturbance (Likert-type scale)
Daytime fatigue (Likert-type scale)
Quality of life - physical and mental domains
No clinical intervention was introduced. Data were analyzed using correlation and regression models to determine predictive associations.
Eligibility Criteria
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Inclusion Criteria
* Symptom duration ≥12 weeks
* Ability to provide informed consent
Exclusion Criteria
* Neurological or psychiatric disorders
* Use of sedatives or sleep-modulating medications
18 Years
65 Years
ALL
No
Sponsors
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Sinai University
OTHER
Responsible Party
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Amany Gomaa Atiaa
lecturer
Locations
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Sinai university
Cairo, , Egypt
Countries
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Other Identifiers
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SU.REC.2025(58H)
Identifier Type: -
Identifier Source: org_study_id
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