FibromyalgiaNCT06579560
Audio Vestibular Assessment in Patients with Fibromyalgia
An observational study of Fibromyalgia, run by Noha Osman at 1 site in Egypt.
Trial 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)… Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Audiovestibular assessment in Patients with Fibromyalgia
- How many people
- 4 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2023to 16 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients diagnosed with Fibromyalgia recruited from the Rheumatology and Rehabilitation Department at Al-Azhar University Hospital
- Inclusion criteria: - Age: 15-50 years.
- Sex: Male \& Female.
- Patients with fulfilling the criteria for the diagnosis of FM
- Exclusion criteria: Patients not fulfilling the criteria for the diagnosis of FM.
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine - Assiut University
Asyut, Asyut Governorate, 71111
Mohamed A. Ali, MA, 01151791724, moahmed300070@gmail.com
About this study
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)
Read the detailed description
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) (FM) is a non-inflammatory chronic disease, characterized by widespread musculoskeletal pain (Tuncer et al., 2021). The etiology is still unknown and (FM) is often misdiagnosed (Tuncer et al., 2021).The estimated prevalence in the general population is between 2 and 11% (Hulens et al., 2023). Although the underling Pathological mechanisms controlling the (FM) have not been determined, neuroendocrine, genetic or molecular factors can be involved (Zeigelboim \& Moreira, 2011).(FM) affects females between the ages of 25 to 65 years old, although it can be seen in all ages and in both sexes (Fitzcharles \& Yunus, 2012), It's more common in females than in males (Müller et al., 2007).
The main symptoms of (FM) include, muscle pain, muscle spasms, insomnia, fatigue, tension, abdominal pain, facial tenderness, sensitivity to noise and bright lights, and central nervous system abnormalities. Various neurological symptoms such as tinnitus, ear fullness, vertigo, and dizziness may also be associated, regardless of the disease severity (Koca et al., 2018) Many patients with FM were reported to have dizziness which may attributed to hypotension and autonomic nervous system (ANS) dysfunction, in this study we want to explore if dizziness and imbalance occur due to these factors only or due to a direct effect of (FM) on the vestibular system (Kanjwal et al., 2010) (Mohamed et al., 2021).
- Conditions
- Fibromyalgia
- Being tested
- Audiovestibular assessment in Patients with Fibromyalgia
- Keywords
- Audiovestibular assessment, Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovestibular assessment in Patients with FibromyalgiaDiagnostic test
Audiovestibular assessment in Patients with Fibromyalgia
What is being measured
The primary outcome is the main question the study is designed to answer.
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)]
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start16 Apr 2023
- Primary completion16 Apr 2025 (estimated)
- Study completion16 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noha Osman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Osman, Assiut University
- Investigators
- Enass S. Mohamed, Professor, Study chair, Assiut UniversityAbdelhafeez M. Moshrif, Professor, Study chair, Assiut UniversityMohamed A. Elmoursy, Professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579560
- Sponsor's protocol ID
- 04-2023-200637
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audio Vestibular Assessment in Patients with Fibromyalgia
- ClinicalTrials.gov ID
- NCT06579560
- Acronym / sponsor ID
- 04-2023-200637
- Conditions
- Fibromyalgia
- Keywords
- Audiovestibular assessment, Fibromyalgia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Noha OsmanUniversity, hospital or other
- Study start
- 16 Apr 2023 (actual)
- Primary completion
- 16 Apr 2025 (estimated)
- Study completion
- 16 Apr 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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) (FM) is a non-inflammatory chronic disease, characterized by widespread musculoskeletal pain (Tuncer et al., 2021). The etiology is still unknown and (FM) is often misdiagnosed (Tuncer et al., 2021).The estimated prevalence in the general population is between 2 and 11% (Hulens et al., 2023). Although the underling Pathological mechanisms controlling the (FM) have not been determined, neuroendocrine, genetic or molecular factors can be involved (Zeigelboim \& Moreira, 2011).(FM) affects females between the ages of 25 to 65 years old, although it can be seen in all ages and in both sexes (Fitzcharles \& Yunus, 2012), It's more common in females than in males (Müller et al., 2007).
The main symptoms of (FM) include, muscle pain, muscle spasms, insomnia, fatigue, tension, abdominal pain, facial tenderness, sensitivity to noise and bright lights, and central nervous system abnormalities. Various neurological symptoms such as tinnitus, ear fullness, vertigo, and dizziness may also be associated, regardless of the disease severity (Koca et al., 2018) Many patients with FM were reported to have dizziness which may attributed to hypotension and autonomic nervous system (ANS) dysfunction, in this study we want to explore if dizziness and imbalance occur due to these factors only or due to a direct effect of (FM) on the vestibular system (Kanjwal et al., 2010) (Mohamed et al., 2021).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with Fibromyalgia recruited from the Rheumatology and Rehabilitation Department at Al-Azhar University Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiovestibular assessment in Patients with FibromyalgiaAudiovestibular assessment in Patients with Fibromyalgia | Diagnostic test | – |
Primary outcome
Hearing Sensitivity
Time frame: 2 years
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)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enass S. Mohamed, Professor study chair
Assiut University
Abdelhafeez M. Moshrif, Professor study chair
Assiut University
Mohamed A. Elmoursy, Professor study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Noha Osman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A. Ali, MA (+201151791724, moahmed300070@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing Sensitivity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.