Sudden Hearing LossIMANCT03706183
Ischemia- Modified Albumin Levels in the Sudden Hearing Loss
An observational study of Sudden Hearing Loss and Ischemia, run by Yuzuncu Yil University.
Trial summary
To evaluate ischemia-modified albumin levels in these patients to investigate the presence of ischemia in patients presenting with sudden hearing loss. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudden Hearing Loss, Ischemia
- What is being tested?
- Ischemia-modified albumin and Hearing thresholds
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 31 Jan 2019
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study group will include the patients with SSHL and control group will include the healthy controls with normal hearing thresholds
Who may be able to join
- Admission with sensorineural hearing loss
Who cannot join
- cardiovascular disease
- hypertension
- diabetes mellitus
- malignancy
- chronic inflammatory disease
- kidney failure
- liver failure
About this study
Official title: 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.
Read the 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.
- Conditions
- Sudden Hearing Loss, Ischemia
- Being tested
- Ischemia-modified albumin, Hearing thresholds
- Medical subject headings
- Hearing Loss, Sudden, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemia-modified albuminDiagnostic test
The biomarker was investigated in many studies and it was associated with the ischemia and tissue injury.
Hearing thresholdsDiagnostic test
Also called audiologic assessment
The hearing levels will be determined for each group.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | The IMA levels will be determined and the association of the IMA and Hearing thresholds will be evaluated. Receives: Diagnostic Test: Ischemia-modified albumin; Diagnostic Test: Hearing thresholds | |
| Control Group | The IMA levels will be determined. Receives: Diagnostic Test: Ischemia-modified albumin; Diagnostic Test: Hearing thresholds |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemia-modified albumin levels
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.
Measured: 1 month
hearing thresholds
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sudden Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ufuk Düzenli, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706183
- Sponsor's protocol ID
- YYU7139
- Acronym
- IMA
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25712982Onal 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.
PubMed 28261890Kilic 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.
PubMed 27769665Can 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.
PubMed 26648996
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Ischemia-modified Albumin Levels in the Patients With Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT03706183
- Acronym / sponsor ID
- IMA / YYU7139
- Conditions
- Sudden Hearing Loss, Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate ischemia-modified albumin levels in these patients to investigate the presence of ischemia in patients presenting with sudden hearing loss.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Ischemia-modified albumin, Diagnostic Test: Hearing thresholdsThe IMA levels will be determined and the association of the IMA and Hearing thresholds will be evaluated. |
| Control Group | – | Diagnostic Test: Ischemia-modified albumin, Diagnostic Test: Hearing thresholdsThe IMA levels will be determined. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study group will include the patients with SSHL and control group will include the healthy controls with normal hearing thresholds
Key inclusion criteria (1 listed)
- Admission with sensorineural hearing loss
Key exclusion criteria (7 listed)
- cardiovascular disease
- hypertension
- diabetes mellitus
- malignancy
- chronic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemia-modified albuminThe biomarker was investigated in many studies and it was associated with the ischemia and tissue injury. | Diagnostic test | Control Group, Study Group |
| Hearing thresholdsAlso: audiologic assessmentThe hearing levels will be determined for each group. | Diagnostic test | Control Group, Study Group |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Results publication: PubMed 25712982Kim 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.
- Results publication: PubMed 28261890Onal 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.
- Results publication: PubMed 27769665Kilic 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.
- Results publication: PubMed 26648996Can 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Hearing Loss and Ischemia, run by Yuzuncu Yil University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemia-modified albumin levels (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03706183, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.