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

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ClinicalTrials.gov Identifier: NCT03919474
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Ludovic Drouet MD, PhD, Hopital Lariboisière

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

Condition or disease Intervention/treatment
Idiopathic SSNHL Age Over 18 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


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Markers of Microvascular Lesion in Adult Patients With Acquired Sudden Cochelo-vestibular Deficiency
Actual Study Start Date : January 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2021



Intervention Details:
  • Diagnostic Test: microvascular markers
    follow up of microvascular biomarkers during patient follow up


Primary Outcome Measures :
  1. change from Baseline of plasma serotonin at three months [ Time Frame: at three months and then once a year up to five years ]
    plasma serotonin level (HPLC, frequent value <15nM)

  2. change from Baseline of plasma homocystein at three months [ Time Frame: at three months and then once a year up to five years ]
    plasma homocystein (HPLC, fequent value <15 µM)

  3. change from Baseline serum of anticardiolipine antibody at three months [ Time Frame: at three months and then once a year up to five years ]
    serum anticardiolipin antiboy (ELISA, frequent value <10units)


Secondary Outcome Measures :
  1. change from Baseline of hearing characteristics at three months [ Time Frame: at three months and then once a year up to five years ]
    audiogram


Biospecimen Retention:   Samples With DNA
venous peripheral blood


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
unrelated adult consecutive outpatients referred for SSNHL to the otolaryngologist clinic of our university hospital
Criteria

Inclusion Criteria:

  • adult idiopathic SSNHL

Exclusion Criteria:

  • secundary hearing loss

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919474


Contacts
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Contact: ludovic 0 Drouet, MD, PhD +33149956414 ludovic.drouet@aphp.fr
Contact: charlotte Hautefort, MD +33149958057 charlotte.hautefort@aphp.fr

Locations
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France
HLariboisier otholaryngology clinic Recruiting
Paris, France, 75010
Contact: charlotte Hautefort, MD    +331499958057    charlotte.hautefort@aphp.fr   
Contact: Romain Kania, MD PhD    +331499956629    romain.kania@aphp.fr   
Principal Investigator: ludovic o Drouet, MD,PHD         
Sponsors and Collaborators
Hopital Lariboisière
Investigators
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Study Director: jean-marie Launay, PharmD, PhD Hopital Lariboisière

Publications of Results:
Other Publications:
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Responsible Party: Ludovic Drouet MD, PhD, Principal Investigator, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT03919474     History of Changes
Other Study ID Numbers: HLariboisiere-ORL
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: it will be decided at completion of patient recruitement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ludovic Drouet MD, PhD, Hopital Lariboisière:
sudden hearing loss,
SSNHL
serotonin
homocystein
antiphospholipid syndrom
thrombophilia

Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms