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

Y

Yuzuncu Yıl University

Status

Unknown

Conditions

Sudden Hearing Loss
Ischemia

Treatments

Diagnostic Test: Hearing thresholds
Diagnostic Test: Ischemia-modified albumin

Study type

Observational

Funder types

Other

Identifiers

NCT03706183
YYU7139

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Admission with sensorineural hearing loss

Exclusion criteria

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

Trial design

60 participants in 2 patient groups

Study Group
Description:
The IMA levels will be determined and the association of the IMA and Hearing thresholds will be evaluated.
Treatment:
Diagnostic Test: Ischemia-modified albumin
Diagnostic Test: Hearing thresholds
Control Group
Description:
The IMA levels will be determined.
Treatment:
Diagnostic Test: Ischemia-modified albumin
Diagnostic Test: Hearing thresholds

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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