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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

Tracking Information
First Submitted Date October 16, 2017
First Posted Date October 19, 2017
Last Update Posted Date October 19, 2017
Estimated Study Start Date March 1, 2018
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 16, 2017)
Taste change in AOM [ Time Frame: 1 week ]
change in taste threshold in AOM patients
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Taste Changes in Acute Otitis Media
Official Title Taste Changes in Acute Otitis Media
Brief Summary Detection of taste changes in Acute Otitis Media (AOM) patients.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with AOM
Condition Acute Otitis Media
Intervention Diagnostic Test: Electrogustometery
Taste assessment using EGM
Study Groups/Cohorts Patients
patients with AOM
Intervention: Diagnostic Test: Electrogustometery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 16, 2017)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2019
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Unilateral AOM

Exclusion Criteria:

  • Chronic Otitis Media
  • Pregnancy
  • Patients with lack of judgment
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03315156
Other Study ID Numbers TASMC-17-AD-0311-17-TLV-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Tel-Aviv Sourasky Medical Center
Study Sponsor Tel-Aviv Sourasky Medical Center
Collaborators Tel Aviv University
Investigators
Principal Investigator: Ari DeRowe, MD TLVMC
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date October 2017