IMA: Ischemia- Modified Albumin Levels in the Sudden Hearing Loss

Sponsor
Yuzuncu Yıl University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03706183
Collaborator
(none)
60
3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ischemia-modified albumin
  • Diagnostic Test: Hearing thresholds

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Evaluation of the Ischemia-modified Albumin Levels in the Patients With Sudden Sensorineural Hearing Loss
Anticipated Study Start Date :
Nov 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2018
Anticipated Study Completion Date :
Jan 31, 2019

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. ischemia-modified albumin levels [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.

    2. hearing thresholds [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Admission with sensorineural hearing loss
    Exclusion Criteria:
    • cardiovascular disease

    • hypertension

    • diabetes mellitus

    • malignancy

    • chronic inflammatory disease

    • kidney failure

    • liver failure

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yuzuncu Yıl University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ufuk Düzenli, Principal Investigator, Assistant Professor, Yuzuncu Yıl University
    ClinicalTrials.gov Identifier:
    NCT03706183
    Other Study ID Numbers:
    • YYU7139
    First Posted:
    Oct 15, 2018
    Last Update Posted:
    Oct 17, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 17, 2018