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

NCT07242040 | Completed DMC

• 1 other identifier: SU.REC.2025(58H)
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Quality of life scale

  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.

  Day 1 (Single assessment at time of survey completion)

Secondary Outcomes (1)

• SNOT-22 Scale

  Day 1 (Single assessment at time of survey completion)

Study Arms (1)

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.

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

Interventions

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.

CRS Patients Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study enrolled adult patients diagnosed with chronic rhinosinusitis (CRS), attending otolaryngology outpatient clinics at \[insert institution name\] during the study period. All participants met clinical diagnostic criteria for CRS as defined by current otolaryngologic guidelines (e.g., symptom duration ≥12 weeks, with or without radiologic confirmation). Eligible individuals were aged 18 years or older, capable of providing informed consent, and willing to complete standardized self-reported questionnaires related to sleep, fatigue, and quality of life. Patients with prior sinus surgery, neurological or psychiatric illness, or those on medications affecting sleep or cognition were excluded.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sinai University: lead

Study Sites (1)

Sinai university

Cairo, 44511, Egypt

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Fatigue; Cognitive Dysfunction; Parasomnias

Interventions

Sleep

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: November 21, 2025
• Study Start: September 15, 2024
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

EG (1)