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临床试验/NCT07242040
NCT07242040已完成不适用

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

Sinai University1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2024年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
1
主要终点
Quality of life scale

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

结局指标

主要结局

Quality of life scale

时间窗: 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.

次要结局

  • SNOT-22 Scale(Day 1 (Single assessment at time of survey completion))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amany Gomaa Atiaa

lecturer

Sinai University

研究点 (1)

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