NCT03315156

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

October 16, 2017

Last Update Submit

October 16, 2017

Conditions

Acute Otitis Media

Keywords

Acute otitis mediaAOMElectrogustometerEGMTaste threshold

Outcome Measures

Primary Outcomes (1)

  • Taste change in AOM

    change in taste threshold in AOM patients

    1 week

Study Arms (1)

Patients

patients with AOM

Diagnostic Test: Electrogustometery

Interventions

ElectrogustometeryDIAGNOSTIC_TEST

Taste assessment using EGM

Patients

Eligibility Criteria

Age8 Years - 40 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with AOM

You may qualify if:

  • Unilateral AOM

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ari DeRowe, MD

    TLVMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ari DeRowe, MD

CONTACT

03-6974517arid@tlvmc.gov.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 19, 2017

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

October 19, 2017

Record last verified: 2017-10