Taste Changes in Acute Otitis Media | NCT03315156

Studies
Taste Changes in Acute Otitis Media

NCT03315156

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Oct 19, 2017Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Acute Otitis Media

Interventions

Electrogustometery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Estimated

Primary Completion Date

Mar 1, 2019Estimated

Completion Date

Mar 1, 2019Estimated

First Submitted Date

Oct 16, 2017

First Submission Date that Met QC Criteria

Oct 16, 2017

First Posted Date

Oct 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2017

Last Update Posted Date

Oct 19, 2017Actual

Name	Class
Tel Aviv University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		patients with AOM	Diagnostic Test: Electrogustometery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electrogustometery	Diagnostic Test	Taste assessment using EGM	Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Taste change in AOM	change in taste threshold in AOM patients	1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unilateral AOM

Exclusion Criteria:

Chronic Otitis Media
Pregnancy
Patients with lack of judgment

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Patients with AOM

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ari DeRowe, MD	Contact	03-6974517		arid@tlvmc.gov.il

Overall Officials

Name	Affiliation	Role
Ari DeRowe, MD	TLVMC	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010033	Otitis Media

Ancestor Terms

ID	Term
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

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Browse Branches

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