Completed

NCT Number: NCT07242040

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

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.

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Key information

Conditions

Chronic Rhinosinusitis Cognition Disorders Cognitive Dysfunction Fatigue Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Quality of Life Impairment Signs and Symptoms Sleep Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sinai university

Cairo, 44511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Reported Questionnaires for Sleep, Fatigue, and Quality of Life

Diagnostic Test

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.

Primary outcomes

Quality of life scale

Time frame: Day 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 outcomes

SNOT-22 Scale

Time frame: Day 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.

Sponsors and collaborators

Lead sponsor

Sinai University

Other

Registry information

Acronym: SNOOZE-CRS

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 21, 2025
Registry last updated: Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed