The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children

Phase 4

• Conditions: Otitis Media; Conductive Hearing Loss

• Registration Number: NCT00393159
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-10
• Study Start: 2006-10
• Study First Submitted: 2006-10-24
• Study First Submitted QC: 2006-10-24
• Last Update Submitted: 2006-10-24
• Study First Posted: 2006-10-26
• Last Update Posted: 2006-10-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hearing improvement at 7 weeks and 3 months from the beginning of the trial.
Rate of referrals for tympanostomy tube insertion at 3 months

Trial Locations

Locations (1)

ENT Unit, Dana Children's Hospital, Tel-Aviv Medical Center; 🇮🇱 Tel-Aviv, Israel