NCT03706183

Brief Summary

To evaluate ischemia-modified albumin levels in these patients to investigate the presence of ischemia in patients presenting with sudden hearing loss.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

October 10, 2018

Last Update Submit

October 12, 2018

Conditions

Sudden Hearing LossIschemia

Outcome Measures

Primary Outcomes (2)

  • ischemia-modified albumin levels

    The investigators will measure the levels of the IMA in the patients with SSHL and control group participants. The measurements will be done at the 1,3, 7 and 10th days and 1st month after diagnosing the SSHL. One measurement will be performed for the control group participants.

    1 month

  • hearing thresholds

    The hearing levels will be determined by an audiologist. The hearing determinations will be performed at the day when IMA measurements will be done for each group.

    1 month

Study Arms (2)

Study Group

The IMA levels will be determined and the association of the IMA and Hearing thresholds will be evaluated.

Diagnostic Test: Ischemia-modified albuminDiagnostic Test: Hearing thresholds

Control Group

The IMA levels will be determined.

Diagnostic Test: Ischemia-modified albuminDiagnostic Test: Hearing thresholds

Interventions

Ischemia-modified albuminDIAGNOSTIC_TEST

The biomarker was investigated in many studies and it was associated with the ischemia and tissue injury.

Control GroupStudy Group
Hearing thresholdsDIAGNOSTIC_TEST

The hearing levels will be determined for each group.

Also known as: audiologic assessment
Control GroupStudy Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study group will include the patients with SSHL and control group will include the healthy controls with normal hearing thresholds

You may qualify if:

  • Admission with sensorineural hearing loss

You may not qualify if:

  • cardiovascular disease
  • hypertension
  • diabetes mellitus
  • malignancy
  • chronic inflammatory disease
  • kidney failure
  • liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Kim JH, Roh KJ, Suh SH, Lee KY. Improvement of sudden bilateral hearing loss after vertebral artery stenting. J Neurointerv Surg. 2016 Mar;8(3):e12. doi: 10.1136/neurintsurg-2014-011595.rep. Epub 2015 Feb 24.

    PMID: 25712982RESULT

  • Onal M, Elsurer C, Selimoglu N, Yilmaz M, Erdogan E, Bengi Celik J, Kal O, Onal O. Ozone Prevents Cochlear Damage From Ischemia-Reperfusion Injury in Guinea Pigs. Artif Organs. 2017 Aug;41(8):744-752. doi: 10.1111/aor.12863. Epub 2017 Mar 5.

    PMID: 28261890RESULT

  • Kilic MO, Guldogan CE, Balamir I, Tez M. Ischemia-modified albumin as a predictor of the severity of acute appendicitis. Am J Emerg Med. 2017 Jan;35(1):92-95. doi: 10.1016/j.ajem.2016.10.010. Epub 2016 Oct 7.

    PMID: 27769665RESULT

  • Can S, Akdur O, Yildirim A, Adam G, Cakir DU, Karaman HI. Myelin basic protein and ischemia modified albumin levels in acute ischemic stroke cases. Pak J Med Sci. 2015 Sep-Oct;31(5):1110-4. doi: 10.12669/pjms.315.7702.

    PMID: 26648996RESULT

MeSH Terms

Conditions

Hearing Loss, SuddenIschemia

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 15, 2018

Study Start

November 1, 2018

Primary Completion

December 31, 2018

Study Completion

January 31, 2019

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share