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临床试验/NCT07424534
NCT07424534尚未招募不适用

Development of Artificial Intelligence-Based Predictive Models to Analyze the Impact of Psychosocial Profile, Fatigue, and Sleep Quality on Disease Severity in Patients With Fibromyalgia

University of Castilla-La Mancha1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Disease severity

研究概览

简要总结

The primary goal of this research project is to develop different prediction models in fibromyalgia disease through the application of machine learning techniques and to assess the explainability of the results. As specific objective the research project intends to evaluate the influence of psychosocial variables, fatigue, and sleep quality on the prediction of disease severity in patients with fibromyalgia using an artificial intelligence-based model.

详细描述

Fibromyalgia (FM) is a condition characterized by chronic musculoskeletal pain, the pathophysiology of which remains unclear. In addition, this disorder is frequently associated with sleep disturbances, pronounced fatigue, morning stiffness, poor quality of life, cognitive alterations (primarily memory-related problems), and psychological disturbances, including depression, anxiety, and stress.

FM is significantly more prevalent in women, with an estimated female-to-male ratio of approximately 3:1. Its prevalence in the adult population is estimated at 2-3%, increasing with age and peaking between 45 and 65 years. The socioeconomic and healthcare burden of this condition is substantial, as FM is associated with high rates of medical consultations, unemployment, work disability, and the need for disability-related financial support.

FM has been linked to higher levels of negative affect, defined as a general state of distress encompassing aversive emotions such as sadness, fear, anger, and guilt. Patients with FM commonly exhibit elevated levels of anxiety, depression, pain catastrophizing, and stress, which are associated with worsening of symptoms, including cognitive impairments.

In recent years, machine learning, data mining, and artificial intelligence (AI) techniques have been successfully applied to the development of computer-aided diagnosis (CAD) systems for the identification of complex health conditions, achieving good levels of accuracy and efficiency by recognizing potentially meaningful patterns in health-related data. Accordingly, these technologies provide powerful tools for multivariable data analysis, enabling model-based predictions and offering a clear advantage in risk assessment across a wide range of diseases. In addition, these approaches not only support the development of clinical predictive models but also enhance clinicians' ability to interpret and apply their results in practice.

Explainable machine learning models allow clinical experts to make data-driven decisions and to deliver personalized treatments while maintaining a high standard of care. These models fall within the field of explainable artificial intelligence (XAI), which aims to develop interpretable models that preserve high predictive accuracy while improving the transparency, understanding, and trustworthiness of model outputs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Age between 18 and 65 years.
  • Fullfilled the 2010 American Collegue of Rheumathology criteria for fibromyalgia.
  • Understanding of spoken and written Spanish.

排除标准

  • Diagnosed psychiatric pathology.
  • Rheumatic pathology not medically controlled.
  • Neurological pathologies that make evaluations difficult.

结局指标

主要结局

Disease severity

时间窗: Baseline

For this purpose, the Spanish validated version of the Fibromyalgia Impact Questionnaire (FIQ) will be used. The questionnaire comprises several components assessing physical, psychological, and social status, as well as overall well-being. It consists of 10 items scored on 0-10 scales, yielding a total score ranging from 0 to 100, with higher scores indicating greater disease impact and poorer quality of life.

次要结局

  • Sleep quality(Baseline)
  • Fatigue(Baseline)
  • Pain intensity(Baseline)
  • Pain catastrophizing(Baseline)
  • Depression(Baseline)
  • Anxiety(Baseline)

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

研究点 (1)

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