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Sleep Disturbance and Daytime Fatigue as Predictors of Cognitive Decline and Functional Decline in Chronic Rhinosinusitis

Sleep Disturbance and Daytime Fatigue as Predictors of Cognitive Decline and Functional Decline in Chronic Rhinosinusitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07242040
Acronym
SNOOZE-CRS
Enrollment
134
Registered
2025-11-21
Start date
2024-09-15
Completion date
2025-09-25
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis, Cognitive Dysfunction, Fatigue, Quality of Life Impairment, Sleep Disorders

Keywords

Quality of Life, Functional Decline, Cognitive Decline, Daytime Fatigue, Sleep Disturbance, Chronic Rhinosinusitis

Brief summary

FOCUS-CRS is a cross-sectional observational study examining the relationship between sleep disturbance, daytime fatigue, and cognitive and functional health in patients with chronic rhinosinusitis (CRS). The study aims to determine whether self-reported sleep and fatigue scores predict impairments in physical and cognitive quality of life domains. A total of 134 adult CRS patients completed structured questionnaires assessing symptom burden and quality of life. Correlational and multivariate regression analyses were conducted to evaluate the predictive role of sleep disturbance and fatigue on functional and cognitive outcomes. This study seeks to improve understanding of underrecognized systemic effects of CRS, with implications for multidisciplinary patient care.

Detailed description

Background: 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.

Interventions

DIAGNOSTIC_TESTSelf-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.

Sponsors

Sinai University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Adults (≥18 years) diagnosed with CRS based on clinical guidelines * Symptom duration ≥12 weeks * Ability to provide informed consent

Exclusion criteria

* Prior sinus surgery * Neurological or psychiatric disorders * Use of sedatives or sleep-modulating medications

Design outcomes

Primary

MeasureTime frameDescription
Quality of life scaleDay 1 (Single assessment at time of survey completion)The SF-36 Health Survey is a well-established instrument for measuring general health and quality of life. It evaluates eight domains of health, including both physical and mental aspects. Two summary scores are derived from these domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Physical Component Summary (PCS): Reflects physical health and functioning, including physical limitations and pain. Mental Component Summary (MCS): Reflects emotional well-being, social functioning, and mental health status.

Secondary

MeasureTime frameDescription
SNOT-22 ScaleDay 1 (Single assessment at time of survey completion)The SNOT-22 is a widely used instrument to evaluate the impact of sinonasal conditions (e.g., chronic rhinosinusitis) on quality of life. It consists of 22 questions that assess symptoms and how these symptoms interfere with daily activities. The questions cover aspects such as nasal symptoms, sleep disturbance, and the impact on social functioning.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026