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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03919474
Acronym
SSNHL
Enrollment
394
Registered
2019-04-18
Start date
2016-01-31
Completion date
2019-12-31
Last updated
2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Over 18, Idiopathic SSNHL

Keywords

sudden hearing loss,, SSNHL, serotonin, homocystein, antiphospholipid syndrom, thrombophilia

Brief summary

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

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

Interventions

DIAGNOSTIC_TESTmicrovascular markers

follow up of microvascular biomarkers during patient follow up

Sponsors

Hopital Lariboisière
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* adult idiopathic SSNHL

Exclusion criteria

* secundary hearing loss

Design outcomes

Primary

MeasureTime frameDescription
change from Baseline of plasma serotonin at three monthsat three months and then once a year up to five yearsplasma serotonin level (HPLC, frequent value \<15nM)
change from Baseline of plasma homocystein at three monthsat three months and then once a year up to five yearsplasma homocystein (HPLC, fequent value \<15 µM)
change from Baseline serum of anticardiolipine antibody at three monthsat three months and then once a year up to five yearsserum anticardiolipin antiboy (ELISA, frequent value \<10units)

Secondary

MeasureTime frameDescription
change from Baseline of hearing characteristics at three monthsat three months and then once a year up to five yearsaudiogram

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026