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
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | ENT Unit, Dana Children's Hospital, Tel-Aviv Medical Center | Tel-Aviv |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Israel,
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 |
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 |
NCT00051753 -
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
|
Phase 3 | |
Completed |
NCT00044473 -
A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat
|
Phase 3 |