Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00393159
Other study ID # TASMC06YO3567CTIL
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
See also
  Status Clinical Trial Phase
Completed NCT04016051 - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections Phase 3
Completed NCT02452164 - Family MobilePhone Otoscopy in Diagnostics of Otitis Media N/A
Completed NCT01199016 - Effect of Prevnar 13 on Ear Infections in Children Phase 4
Terminated NCT00778063 - Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients N/A
Completed NCT00195611 - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media Phase 4
Recruiting NCT03722160 - Clinical Study of the Solo Tympanostomy Tube Device N/A
Recruiting NCT04447521 - Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
Active, not recruiting NCT05127161 - Broad Implementation of Outpatient Stewardship N/A
Completed NCT02600559 - Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes Phase 3
Completed NCT01444391 - inVENT-visIOn Study N/A
Enrolling by invitation NCT01437436 - The Effect of Obesity on Ventilation Tube Insertion N/A
Completed NCT01003210 - Homeopathic Ear Drops for Otitis Media Study N/A
Completed NCT00768534 - Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media N/A
Completed NCT00617682 - Maternal Immunization To Prevent Infant Otitis Media Phase 1/Phase 2
Withdrawn NCT00956748 - N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media Phase 4
Withdrawn NCT01908764 - Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery Phase 1
Recruiting NCT01619462 - Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children Phase 3
Completed NCT02616458 - The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population N/A
Completed NCT00781521 - Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children Phase 3
Completed NCT00051753 - Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media Phase 3