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

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

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

Study Overview

• Status: Completed
• Conditions: Idiopathic SSNHL; Age Over 18
• Intervention / Treatment: Diagnostic test: microvascular markers

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

• Study Type: Observational
• Enrollment (Actual): 394

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • HLariboisier otholaryngology clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

unrelated adult consecutive outpatients referred for SSNHL to the otolaryngologist clinic of our university hospital

Description

Inclusion Criteria:

• adult idiopathic SSNHL

Exclusion Criteria:

• secundary hearing loss

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hopital Lariboisière
• Investigators: Study Director: jean-marie Launay, PharmD, PhD, Hôpital Lariboisière

Publications and helpful links

General Publications

• Callebert J, Esteve JM, Herve P, Peoc'h K, Tournois C, Drouet L, Launay JM, Maroteaux L. Evidence for a control of plasma serotonin levels by 5-hydroxytryptamine(2B) receptors in mice. J Pharmacol Exp Ther. 2006 May;317(2):724-31. doi: 10.1124/jpet.105.098269. Epub 2006 Feb 3.
• Brand T, Anderson GM. The measurement of platelet-poor plasma serotonin: a systematic review of prior reports and recommendations for improved analysis. Clin Chem. 2011 Oct;57(10):1376-86. doi: 10.1373/clinchem.2011.163824. Epub 2011 Aug 22.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: serotonin; thrombophilia; SSNHL; sudden hearing loss,; homocystein; antiphospholipid syndrom
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: HLariboisiere-ORL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: it will be decided at completion of patient recruitement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No