Audio Vestibular Assessment in Patients with Fibromyalgia
1 other identifier
observational
4
1 country
1
Brief Summary
Fibromyalgia (FM) is a common rheumatic illness distinguished by chronic pain, fatigue, cognitive problems, and functional disability. However, the differences between men and women have not yet been comprehensively studied, especially after the development of the last 2016 American College of Rheumatology (ACR) criteria. The disease is more common and more severe in female patients according to a study on gender differences among Egyptian patients (A. Moshrif et al., 2023)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2023
CompletedFirst Submitted
Initial submission to the registry
August 12, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2025
CompletedAugust 30, 2024
August 1, 2024
2 years
August 12, 2024
August 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hearing Sensitivity
Measurement of hearing sensitivity using pure tone audiometry. The outcome will be expressed as hearing thresholds in decibels (dB) at various frequencies (e.g., 250 Hz, 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz). \[Unit of Measure: Decibels (dB)\]
2 years
Interventions
Audiovestibular assessment in Patients with Fibromyalgia
Eligibility Criteria
Patients diagnosed with Fibromyalgia recruited from the Rheumatology and Rehabilitation Department at Al-Azhar University Hospital
You may qualify if:
- Sex: Male \& Female.
- Patients with fulfilling the criteria for the diagnosis of FM
You may not qualify if:
- Other causes of SNHL as Meniere's disease.
- Other causes of Conductive hearing loss (CHL) as chronic suppurative otitis media CSOM.
- Other causes of collagen and connective tissue diseases.
- Abnormal EMG.
- Abnormal radiological studies of the brain.
- Patients are receiving of ototoxic drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Noha Osmanlead
Study Sites (1)
Faculty of Medicine - Assiut University
Asyut, Asyut Governorate, 71111, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Enass S. Mohamed, Professor
Assiut University
- STUDY CHAIR
Abdelhafeez M. Moshrif, Professor
Assiut University
- STUDY CHAIR
Mohamed A. Elmoursy, Professor
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
August 12, 2024
First Posted
August 30, 2024
Study Start
April 16, 2023
Primary Completion
April 16, 2025
Study Completion
April 16, 2025
Last Updated
August 30, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share