Blood Markers in Adult Patients With Sudden Sensorineural Hearing Loss (SSNHL)

Study Overview
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Brief Summary
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The roles of thrombophilia and cardiovascular risk factors in sudden sensorineural hearing loss (SSNHL) remain controversial. Cochlear micro-thrombosis has been hypothesized as a possible pathogenic mechanism of SSNHL. The objective was thus to measure the levels of markers of macrovascular thrombosis and microvascular risk factors

Detailed Description
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To recruit adult consecutive outpatients referred for SSNHL to the otolaryngologist clinic of our university hospital starting June 2016 and prospectively until december 31th 2018. Plasma sampling and biomarkers quantification : After a 48-hours diet excluding serotonin- and tryptophan-rich food, fasting blood samples were collected into vacuum tubes containing 109 mM sodium citrate (Becton-Dickinson, Le Pont de Claix, France) with a 9:1 blood-to-anticoagulant ratio. After removing 0.5 mL of whole blood for serotonin measurements, the remainder was centrifuged at 1,000 x g for 10 minutes, and the supernatant was then centrifuged at 3,000 x g for 15 minutes to isolate platelets and obtain platelet-poor plasma. Importantly, the time between blood sampling and platelet/plasma isolation was less than one hour. Aliquots of whole blood, platelets, and plasma were kept frozen (-20°C) until serotonin and homocysteine measurements performed within one week after congelation. Whole blood, platelet and plasma 5-HT as well as plasma homocysteine (Hcy) levels were measured by high pressure liquid chromatography coupled to fluorimetric detections . Thrombophilia screening included measurements of antithrombin , protein C, protein S, factor V Leiden, prothrombin G20210A, methylene tetrahydrofolate reductase (MTHFR) C677T, antiphospholipid antibodies anticardiolipin IgG and IgM and anti-beta2 glycoprotein 1 IgG), dilute Russell viper venom time , Rosner index, factor VIII, von Willebrand factor (vWF) activity and antigen. Tests were performed on citrated plasma, serum or DNA as appropriate and as previously described

Official Title
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Markers of Microvascular Lesion in Adult Patients With Acquired Sudden Cochelo-vestibular Deficiency

Conditions
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Idiopathic SSNHL, Age Over 18

Intervention / Treatment
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* Diagnostic Test: microvascular markers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult idiopathic SSNHL Exclusion Criteria: secundary hearing loss

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: microvascular markers|follow up of microvascular biomarkers during patient follow up|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from Baseline of plasma serotonin at three months | plasma serotonin level (HPLC, frequent value <15nM) | at three months and then once a year up to five years | 
| change from Baseline of plasma homocystein at three months | plasma homocystein (HPLC, fequent value <15 µM) | at three months and then once a year up to five years | 
| change from Baseline serum of anticardiolipine antibody at three months | serum anticardiolipin antiboy (ELISA, frequent value <10units) | at three months and then once a year up to five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from Baseline of hearing characteristics at three months | audiogram | at three months and then once a year up to five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sudden hearing loss,, SSNHL, serotonin, homocystein, antiphospholipid syndrom, thrombophilia