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Otitis Media With Effusion clinical trials

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NCT ID: NCT02716376 Completed - Hearing Loss Clinical Trials

Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy

Start date: April 2016
Phase: N/A
Study type: Interventional

To investigate the incidence of tuba dysfunction (TD) and middle ear (ME) morbidity after radiotherapy (RT) to the Head & Neck and test the effect of auto-inflation of the Eustachian tube (ET) on middle ear effusion with a special designed balloon (Otovent®) and thereby better hearing and ear related quality of life after cancer treatment.

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: 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.

NCT ID: NCT02436304 Completed - Clinical trials for Otitis Media With Effusion in Children

Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2

Start date: June 19, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).

NCT ID: NCT02432105 Completed - Clinical trials for Otitis Media With Effusion in Children

Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)

Start date: June 25, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).

NCT ID: NCT02409693 Withdrawn - Clinical trials for Otitis Media With Effusion (OME)

Retrospective Analysis of Perioperative Anesthetic Care and Analgesia Management of Patient Undergoing Bilateral Myringotomy With Tube Insertion

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

This is a retrospective chart review. The purpose of this study is to retrospectively examine the use of perioperative analgesics on the incidence of postoperative pain and emergence delirium in patients undergoing bilateral myringotomy with tube insertion (BTI), as well as events associated with treatment including postoperative vomiting and time to discharge.

NCT ID: NCT02350998 Completed - Clinical trials for Bilateral Middle Ear Effusion

Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration

Start date: January 2015
Phase: Phase 3
Study type: Interventional

This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.