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Taste Changes in Acute Otitis Media

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03315156
Recruitment Status : Unknown
Verified October 2017 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 19, 2017
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:
Detection of taste changes in Acute Otitis Media (AOM) patients.

Condition or disease Intervention/treatment
Acute Otitis Media Diagnostic Test: Electrogustometery

Detailed Description:

Methods:

Taste assessment will be done using Electrogustometer (EGM). Tongue stimulation will be performed using low currents of up to 100uA. Using the protocol as specified in the EGM user manual.

Population: 40 Unilateral AOM patients, aged 8-40. Without chronic otitis media, pregnancy or impaired judgement.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Taste Changes in Acute Otitis Media
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients
patients with AOM
Diagnostic Test: Electrogustometery
Taste assessment using EGM




Primary Outcome Measures :
  1. Taste change in AOM [ Time Frame: 1 week ]
    change in taste threshold in AOM patients



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with AOM
Criteria

Inclusion Criteria:

  • Unilateral AOM

Exclusion Criteria:

  • Chronic Otitis Media
  • Pregnancy
  • Patients with lack of judgment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315156


Contacts
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Contact: Ari DeRowe, MD 03-6974517 arid@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Tel Aviv University
Investigators
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Principal Investigator: Ari DeRowe, MD TLVMC

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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT03315156     History of Changes
Other Study ID Numbers: TASMC-17-AD-0311-17-TLV-CTIL
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tel-Aviv Sourasky Medical Center:
Acute otitis media
AOM
Electrogustometer
EGM
Taste threshold
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases