Ischemia- Modified Albumin Levels in the Sudden Hearing Loss

NCT ID: NCT03706183

Last Updated: 2018-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-01-31

Brief Summary

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

Detailed Description

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Sudden hearing loss is an ENT emergence occurring within 72 hours, with sensorineural hearing loss of more than 30 dB on three consecutive frequencies. The incidence of this disease was 5-20 / 100000. The etiology of this disease has not been fully elucidated. In addition, viral infections, tumors, autoimmune diseases and vascular insufficiency have been suggested as etiologic factors by different researchers. There is no definitive routine treatment modality in the world because the etiology is not fully established. However, corticosteroid treatment is a well-accepted agent for the treatment of internal ear damage. In recent years, studies have shown that ischemia has an important place in etiology and hyperbaric oxygen therapy has become one of the routine treatment protocols. Another important point in terms of the prognosis of the disease is that spontaneous recovery of sudden hearing loss in 30-70% of the patients is observed in different studies.

Ischemia-modified albumin is a compound used as a marker of oxidative stress and used to determine the severity of cardiac ischemia.

In this study, the levels of ischemia-modified albumin levels in patients with SSHL and healthy control patients will be measured and their effectiveness in revealing the etiology of SSHL will be investigated. The difference between ischemia-modified albumin between patients and healthy control subjects will be evaluated. The number of patients and control groups shall be 30 individuals.

The evaluation of the hearing of the patients with hearing loss will be performed by the Otorhinolaryngology Department of Yuzuncu Yıl University. The study is planned to be performed with a total of 30 patients aged 18-50 years. Those who are diagnosed with SSHL will be included in the group and chronic diseases in the ear will be excluded. Thirty healthy patients with similar age and gender will be included in the study as the control group. The patients in the control group, must have normal hearing levels. The amounts of ischemic modified albumin in the study group and in the control group will be measured. Hearing levels will be determined at the admission time and 3,7,10th days and 1st month. 5 ml of peripheral blood samples taken from both groups of patients will be taken into biochemistry tubes. The blood will be centrifuged at 4000 rpm for 5 minutes to separate from the serum and plasma. Serum samples obtained will be stored at -20 oC until analysis. The selected samples are not hemolyzed and lipemic. Once the target number has been reached, all samples will be carefully mixed and then returned to the room temperature (15ına18 oC). It will be examined on the same day to avoid any differences between all sera. Statistical analysis will be done and interpreted.

Conditions

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Sudden Hearing Loss Ischemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

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

Ischemia-modified albumin

Intervention Type DIAGNOSTIC_TEST

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

Hearing thresholds

Intervention Type DIAGNOSTIC_TEST

The hearing levels will be determined for each group.

Control Group

The IMA levels will be determined.

Ischemia-modified albumin

Intervention Type DIAGNOSTIC_TEST

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

Hearing thresholds

Intervention Type DIAGNOSTIC_TEST

The hearing levels will be determined for each group.

Interventions

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Ischemia-modified albumin

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

Intervention Type DIAGNOSTIC_TEST

Hearing thresholds

The hearing levels will be determined for each group.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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audiologic assessment

Eligibility Criteria

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Inclusion Criteria

* Admission with sensorineural hearing loss

Exclusion Criteria

* cardiovascular disease
* hypertension
* diabetes mellitus
* malignancy
* chronic inflammatory disease
* kidney failure
* liver failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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Ufuk Düzenli

Principal Investigator, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 25712982 (View on PubMed)

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.

Reference Type RESULT
PMID: 28261890 (View on PubMed)

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.

Reference Type RESULT
PMID: 27769665 (View on PubMed)

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.

Reference Type RESULT
PMID: 26648996 (View on PubMed)

Other Identifiers

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YYU7139

Identifier Type: -

Identifier Source: org_study_id

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