NCT00393159

Brief Summary

This study is designed to check the effect of the use of the ear popper device on serous otitis media in children and on the conductive hearing loss accompanying the otitis. It is intended that 30 children aged 3-18 years will participate in the study. The inclusion criteria are : clinical serous otitis media for a duration of more then 3 months, a conductive hearing loss of at least 15 decibels air bone gap and tympanometry type B or C. The children will use the ear popper for 7 weeks. They will undergo otologic examination, audiometry and tympanometry at the beginning ao the trial, at 7 weeks and at 3 months from the beginning of the trial. The otologic findings and the audiometry and tympanometry results before and after the trial will be compared. We will try to determine whether the use of the ear popper in the test group will improve the conductive hearing loss and prevent the need for tympanostomy tube insertion.

Trial Health

55
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Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
Last Updated

October 26, 2006

Status Verified

October 1, 2006

First QC Date

October 24, 2006

Last Update Submit

October 24, 2006

Conditions

Otitis MediaConductive Hearing Loss

Keywords

EffusionOtitisMediaEarPopperChildren

Outcome Measures

Primary Outcomes (2)

  • Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.

  • Otoscopic findings at at 7 weeks and 3 months from beginning of use of the ear popper.

Secondary Outcomes (2)

  • Hearing improvement at 7 weeks and 3 months from the beginning of the trial.

  • Rate of referrals for tympanostomy tube insertion at 3 months

Interventions

Ear PopperDEVICE

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Serous Otitis Media for More Then 3 months
  • Conductive Hearing Loss of More Then 15 decibels.
  • Tympanometry type B or C.

You may not qualify if:

  • No History of Tympanostomy Tube Insertion or Adenoidectomy
  • No Cranio or Facial Malformations
  • No Acute Upper Respiratory Tract Infection or Acute Otitis Media

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ENT Unit, Dana Children's Hospital, Tel-Aviv Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Otitis MediaHearing Loss, ConductiveOtitis

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesHearing LossHearing DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yael Oestreicher, MD

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yael Oestreicher, MD

CONTACT

972-3-6974517dkyo@barak-online.net.il

Ari DeRowe, MD

CONTACT

972-3-6974517

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 26, 2006

Study Start

October 1, 2006

Last Updated

October 26, 2006

Record last verified: 2006-10

Locations

IL(1)