ClinicalTrials.Veeva

Menu

Sleep Disturbance and Daytime Fatigue as Predictors of Cognitive Decline and Functional Decline in Chronic Rhinosinusitis (SNOOZE-CRS)

S

Sinai University

Status

Completed

Conditions

Sleep Disorders
Chronic Rhinosinusitis
Quality of Life Impairment
Cognitive Dysfunction
Fatigue

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT07242040
SU.REC.2025(58H)

Details and patient eligibility

About

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.

Full 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.

Enrollment

134 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

134 participants in 1 patient group

CRS Patients Group
Description:
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.
Treatment:
Diagnostic Test: Self-Reported Questionnaires for Sleep, Fatigue, and Quality of Life

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems