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Otitis clinical trials

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NCT ID: NCT02567825 Completed - Acute Otitis Media Clinical Trials

Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

Start date: November 2015
Phase: N/A
Study type: Interventional

To determine whether tympanostomy tube placement (TTP) compared with nonsurgical management will meaningfully improve children's acute otitis media (AOM) experience over the succeeding 2 years.

NCT ID: NCT02567747 Completed - Pneumonia Clinical Trials

Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age

Start date: October 1, 2015
Phase:
Study type: Observational

The purpose of this study is to provide data on trends of morbidity due to Acute Otitis Media (AOM) (primary analysis) and morbidity and mortality due to pneumonia, and AOM related health care resources before and after the introduction of vaccination against pneumococcal disease within the Universal Mass Vaccination (UMV) in Colombia.

NCT ID: NCT02549612 Not yet recruiting - Acute Otitis Media Clinical Trials

The Effect of Early Non-Surgical Treatment of Children With Middle Ear Effusion on the Hearing

Start date: March 2017
Phase: N/A
Study type: Interventional

Secretory otitis media (SOM) or middle ear effusion is a common finding after acute otitis media (AOM). It is usually associated with 5-15 deci Bells hearing loss. Although spontaneous resolution with normalisation of hearing is the usual outcome, this can take several months. Secretory otitis media is the most common cause of hearing impairment in the paediatric age group. When the hearing loss caused by SOM is bilateral and persists for 3-6 months or more, surgery with tympanostomy tube insertion under general anaesthesia is indicated. In Sweden, 10000 children undergo this operation annually. Although many children with unilateral or bilateral SOM improve in the summer, the problem usually recurs in the autumn or winter. The cost of SOM for the Swedish society was 600 million Swedish crowns 2005. In two previous studies, the investigators concluded that the nonsurgical treatment method, that was developed to assist children with SOM equalising their middle ear pressure, could normalise the hearing level in 80 % of children with SOM of minimum duration of 3 months. These children avoided therefore grommet insertion. The investigators would like to assess the effect of this new treatment method on hearing directly after AOM. The investigators expect that using the new method could rapidly normalise hearing in these cases and thereby operation with grommet insertion could be avoided.

NCT ID: NCT02546518 Recruiting - Clinical trials for Secretory Otitis Media

A Comparison of Surgical and a New Non-Surgical Treatment Methods for Secretory Otitis Media in Children

Start date: September 2015
Phase: N/A
Study type: Interventional

Secretory otitis media (SOM) or middle ear effusion is a common finding affecting children in the age of 4-5 years. It is usually associated with 5-15 deci Bells hearing loss. Although spontaneous resolution with normalisation of hearing is the usual outcome, this can take several months. Secretory otitis media is the most common cause of hearing impairment in the paediatric age group. When the hearing loss caused by SOM is bilateral and persists for 3-6 months or more, surgery with tympanostomy tube insertion under general anaesthesia is indicated. In Sweden, 10000 children undergo this operation annually. Although many children with unilateral or bilateral SOM improve in the summer, the problem usually recurs in the autumn or winter. The cost of SOM for the Swedish society was 600 million Swedish crowns 2005. In two previous studies, the investigators concluded that the nonsurgical treatment method, that was developed to assist children with SOM equalising their middle ear pressure, could normalise the hearing level in 80 % of children with SOM of minimum duration of 3 months. These children avoided therefore grommet insertion. The investigators would like to assess the effect of this new treatment method on mainly the hearing threshold of children with SOM. The investigators expect that using the new method could help children with SOM avoid operation with grommet insertion.

NCT ID: NCT02541760 Completed - Clinical trials for Otitis Media With Effiusion

Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children

Start date: April 2014
Phase: Phase 3
Study type: Interventional

Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.

NCT ID: NCT02539654 Completed - Clinical trials for Otitis Media With Effusion in Children

Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)

Start date: November 17, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.

NCT ID: NCT02521597 Completed - Acute Otitis Media Clinical Trials

Mobile Otoscopy - Efficacy of Residents to Diagnose Acute Otitis Media Using a Smartphone Otoscope Attachment

MOTO
Start date: August 2015
Phase: N/A
Study type: Interventional

To evaluate the residents' efficacy in diagnosing acute otitis media among febrile children presenting with respiratory symptoms using a smartphone otoscope attachment compared with a classic otoscope.

NCT ID: NCT02511561 Completed - Otitis Externa Clinical Trials

OTO-201 for the Treatment of Otitis Externa

Start date: July 2015
Phase: Phase 2
Study type: Interventional

This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.

NCT ID: NCT02490332 Terminated - Otitis Media Clinical Trials

The Effects of Ventilation Tubes - The SIUTIT Trial

SIUTIT
Start date: February 2016
Phase: N/A
Study type: Interventional

The prevalence of otitis media among Greenlandic children is one of the highest in the world and twenty per cent of schoolchildren have impaired hearing in the frequencies for normal speech. Yet, there are no national guidelines to ensure prevention and treatment of recurrent acute otitis media and chronic otitis media with effusion and impaired hearing in Greenlandic children. International studies from the developed part of the world have shown that otitis prone children may benefit from tubulation of the tympanic membrane. However, it is unknown if these results can be applied to Greenlandic children. This PhD project will conduct a randomised controlled trial comparing tubulation of the tympanic membrane, in Greenlandic children aged 9-36 months with recurrent acute otitis media and/or chronic otitis media with effusion, to conservative treatment. The children will be followed for two years. Outcome measures will include number of visits to health clinics, number of tympanic membrane perforations, number of episodes with acute otitis media according to medical records, Quality of life, measured by the validated questionnaires OM6 and Caregiver Impact Questionnaire, number of episodes where per oral or intravenous antibiotics have been administered according to medical records and serious adverse events The trial will be conducted in collaboration with the Greenlandic health authorities and Copenhagen Trial Unit. With this trial the investigators hope to decrease the number of episodes with acute otitis media, the number of Greenlandic children with chronic perforations of the tympanic membrane and hearing impairment and increase quality of life. The results will add important knowledge to the effect of ventilation tube treatment also in an international aspect. There are to date only less than a handful of high quality studies concerning this issue on an international basis. The study will be among the first addressing this problem among populations with high risk of otitis media and is also of interest to other indigenous populations and the developing part of the world.

NCT ID: NCT02477735 Not yet recruiting - Sleep Disturbances Clinical Trials

The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion

Start date: June 2015
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the prevalence of sleep disturbances in children with Chronic Otitis Media with Effusion (COME) and the effect of tympanostomy tube insertion (TTI) on sleep disturbances.