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

Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00393159
• Other study ID #: TASMC06YO3567CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: October 24, 2006
• Last updated: October 24, 2006
• Start date: October 2006

Study information

• Verified date: October 2006
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Yael Oestreicher, MD
• Phone: 972-3-6974517
• Email: dkyo[@]barak-online.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Otitis
• Otitis Media

Intervention

Device:
• Ear Popper

Locations

Country	Name	City	State
Israel	ENT Unit, Dana Children's Hospital, Tel-Aviv Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.
Primary	Otoscopic findings at at 7 weeks and 3 months from beginning of use of the ear popper.
Secondary	Hearing improvement at 7 weeks and 3 months from the beginning of the trial.
Secondary	Rate of referrals for tympanostomy tube insertion at 3 months