Predictive Models on Psychosocial Profile, Fatigue and Sleep Quality

NCT07424534 | Not Yet Recruiting

• 1 other identifier: FibroIA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Disease severity

  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.

  Baseline

Secondary Outcomes (6)

• Sleep quality

  Baseline

• Fatigue

  Baseline

• Pain intensity

  Baseline

• Depression

  Baseline

• Pain catastrophizing

  Baseline

Eligibility Criteria

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

Study Population

The study population will consist of adult volunteers diagnosed with fibromyalgia who meet the eligibility criteria and provide written informed consent to participate in the study. Participants will be recruited from a primary care center within the Spanish public healthcare system.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Tampere University: collaborator
• Andaluz Health Service: collaborator

Study Sites (1)

Rafael Velasco Velasco

Seville, Seville, 41008, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Rafael Velasco Velasco, Mr.

  University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael Velasco Velasco, Mr.

CONTACT

+34954786735; Rafael.Velasco@uclm.es

Rubén Arroyo Fernández, Dr.

CONTACT

+34925803600; Ruben.Arroyo@uclm.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

ES (1)