Investigation of Autonomic Dysfunction in Patients With Familial Mediterranean Fever
NCT ID: NCT05596643
Last Updated: 2022-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2022-03-15
2022-10-31
Brief Summary
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The aim of this study was to determine autonomic dysfunction symptoms and objective findings in patients with FMF; Demographic characteristics, disease characteristics, inflammatory burden, fatigue level, sleep quality, presence of fibromyalgia and their relationship with quality of life were evaluated and compared with healthy controls.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Patients diagnosed with Familial Mediterranean Fever
Composite Autonomic Symptom Score-31
Standardized questionnaire to determine the level of autonomic dysfunction
r-r interval variability with normal breathing
electrophysiological test to detect parasympathetic dysfunction
r-r interval variability with deep breathing
electrophysiological test to detect parasympathetic dysfunction
Valsalva ratio
electrophysiological test to detect parasympathetic dysfunction
30:15 ratio
electrophysiological test to detect parasympathetic dysfunction
sympathetic skin response
electrophysiological test to detect sympathetic dysfunction
blood pressure response to standing
clinical test to detect sympathetic dysfunction
blood pressure response to sustained handgrip test
clinical test to detect sympathetic dysfunction
Hospital anxiety and depression scale
Standardized questionnaire to investigate the depression and anxiety
Fibromyalgia rapid screening tool
Standardized questionnaire to determine the presence of fibromyalgia
Familial Mediterranean Fever Quality of life scale
Standardized questionnaire to investigate the quality of life in Familial Mediterranean Fever patients
Jenkins Sleep Evaluation Scale
Standardized questionnaire to investigate the sleep quality and disturbance
The Fatigue Severity Scale
Standardized questionnaire to investigate the fatigue severity
Healthy Controls
Composite Autonomic Symptom Score-31
Standardized questionnaire to determine the level of autonomic dysfunction
r-r interval variability with normal breathing
electrophysiological test to detect parasympathetic dysfunction
r-r interval variability with deep breathing
electrophysiological test to detect parasympathetic dysfunction
Valsalva ratio
electrophysiological test to detect parasympathetic dysfunction
30:15 ratio
electrophysiological test to detect parasympathetic dysfunction
sympathetic skin response
electrophysiological test to detect sympathetic dysfunction
blood pressure response to standing
clinical test to detect sympathetic dysfunction
blood pressure response to sustained handgrip test
clinical test to detect sympathetic dysfunction
Hospital anxiety and depression scale
Standardized questionnaire to investigate the depression and anxiety
Fibromyalgia rapid screening tool
Standardized questionnaire to determine the presence of fibromyalgia
Jenkins Sleep Evaluation Scale
Standardized questionnaire to investigate the sleep quality and disturbance
The Fatigue Severity Scale
Standardized questionnaire to investigate the fatigue severity
Interventions
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Composite Autonomic Symptom Score-31
Standardized questionnaire to determine the level of autonomic dysfunction
r-r interval variability with normal breathing
electrophysiological test to detect parasympathetic dysfunction
r-r interval variability with deep breathing
electrophysiological test to detect parasympathetic dysfunction
Valsalva ratio
electrophysiological test to detect parasympathetic dysfunction
30:15 ratio
electrophysiological test to detect parasympathetic dysfunction
sympathetic skin response
electrophysiological test to detect sympathetic dysfunction
blood pressure response to standing
clinical test to detect sympathetic dysfunction
blood pressure response to sustained handgrip test
clinical test to detect sympathetic dysfunction
Hospital anxiety and depression scale
Standardized questionnaire to investigate the depression and anxiety
Fibromyalgia rapid screening tool
Standardized questionnaire to determine the presence of fibromyalgia
Familial Mediterranean Fever Quality of life scale
Standardized questionnaire to investigate the quality of life in Familial Mediterranean Fever patients
Jenkins Sleep Evaluation Scale
Standardized questionnaire to investigate the sleep quality and disturbance
The Fatigue Severity Scale
Standardized questionnaire to investigate the fatigue severity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Being between the ages of 18-65
2. Having a definite diagnosis of Familial Mediterranean Fever according to Livneh criteria
Healthy control group;
1. Being between the ages of 18-65
2. Absence of any disease diagnosis
Exclusion Criteria
2. Pregnancy
3. Diabetes mellitus
4. Thyroid diseases
5. Those who use neuroprotective or antihypertensive drugs
6. Vitamin B12 deficiency
7. Anemia
8. Paraneoplastic neuropathy
9. Alcoholism
10. Cardiac failure
11. Cardiac arrhythmia
12. Acute thrombosis
13. Having a diagnosis of another systemic rheumatic disease
14. Persons who did not give consent to participate in the study
18 Years
65 Years
ALL
Yes
Sponsors
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Marmara University
OTHER
Responsible Party
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Principal Investigators
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Mehmet Tuncay Duruöz, Prof
Role: PRINCIPAL_INVESTIGATOR
Marmara University
Locations
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Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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09.2021.1427
Identifier Type: -
Identifier Source: org_study_id
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