Ischemia- Modified Albumin Levels in the Sudden Hearing Loss (IMA)

October 12, 2018 updated by: Ufuk Düzenli, Yuzuncu Yıl University

The Evaluation of the Ischemia-modified Albumin Levels in the Patients With Sudden Sensorineural Hearing Loss

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Admission with sensorineural hearing loss

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
The IMA levels will be determined and the association of the IMA and Hearing thresholds will be evaluated.
Diagnostic test: Ischemia-modified albumin
The biomarker was investigated in many studies and it was associated with the ischemia and tissue injury.
Diagnostic test: Hearing thresholds
The hearing levels will be determined for each group.
Other Names:
  • audiologic assessment
Control Group
The IMA levels will be determined.
Diagnostic test: Ischemia-modified albumin
The biomarker was investigated in many studies and it was associated with the ischemia and tissue injury.
Diagnostic test: Hearing thresholds
The hearing levels will be determined for each group.
Other Names:
  • audiologic assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischemia-modified albumin levels
Time Frame: 1 month
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
Time Frame: 1 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

January 31, 2019

Study Registration Dates

First Submitted

October 10, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YYU7139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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