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

NCT03919474 | Completed DMC

• 1 other identifier: HLariboisiere-ORL
• Study Type: observational
• Target: 394
• Locations: 1 country
• Sites: 1

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

Conditions

Idiopathic SSNHL; Age Over 18

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• change from Baseline of hearing characteristics at three months

  at three months and then once a year up to five years

Interventions

microvascular markers DIAGNOSTIC_TEST

follow up of microvascular biomarkers during patient follow up

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• adult idiopathic SSNHL

You may not qualify if:

• secundary hearing loss

Sponsors & Collaborators

• Hopital Lariboisière: lead

Study Sites (1)

HLariboisier otholaryngology clinic

Paris, 75010, France

Location

Related Publications (2)

• 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.

  PMID: 16461587 BACKGROUND

• 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.

  PMID: 21859903 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

venous peripheral blood

MeSH Terms

Conditions

Hearing Loss, Sudden; Thrombophilia

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• jean-marie Launay, PharmD, PhD

  Hopital Lariboisière

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 18, 2019
• Study Start: January 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

FR (1)