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

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ClinicalTrials.gov Identifier: NCT03706183
Recruitment Status : Unknown
Verified October 2018 by Ufuk Düzenli, Yuzuncu Yıl University.
Recruitment status was:  Not yet recruiting
First Posted : October 15, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ufuk Düzenli, Yuzuncu Yıl University

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
Sudden Hearing Loss Ischemia 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: The Evaluation of the Ischemia-modified Albumin Levels in the Patients With Sudden Sensorineural Hearing Loss
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 31, 2019


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 Name: 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 Name: audiologic assessment




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

  • Admission with sensorineural hearing loss

Exclusion Criteria:

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

Publications of Results:
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Responsible Party: Ufuk Düzenli, Principal Investigator, Assistant Professor, Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT03706183    
Other Study ID Numbers: YYU7139
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sudden
Ischemia
Pathologic Processes
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases