Clinical trials: Otologic Disease
Acute Otitis Media, Acute Otitis Externa
Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
Acute otitis media (AOM), defined as acute inflammation in the middle ear, is a leading cause of health encounters and antimicrobial prescriptions in children worldwide.
- Trial name
- NCT02918773
- Testing
- Smartphone otoscope, Conventional otoscope
- Where
- 2 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Emory University
Hearing Loss, Ear Diseases
Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
This is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a HiResolution Bionic Ear System.
- Conditions
- Hearing Loss, Ear Diseases, Hearing Disorders, Otolaryngological Disease
- Trial name
- NCT05034731
- Testing
- Remote Fitting, In-Office Fitting
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Advanced Bionics
Hearing Loss
Littlears Auditory Questionnaire: Validation Study in CI Children
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years.
- Trial name
- LittlEars (NCT00785707)
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Med-El Corporation
Brain Tumor, Central Nervous System Tumor
Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing…
- Conditions
- Brain Tumor, Central Nervous System Tumor, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor
- Trial name
- NCT00716976
- Testing
- sodium thiosulfate, examination
- Where
- 76 sites in United States, Australia and 1 more
- Volunteers
- 131 people
- Sponsor
- Children's Oncology Group
Otomycosis
Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)
This study involves two portions, a randomized, double-blind portion and an open-label portion, to evaluate the efficacy and safety of Miconazole oil 2% versus its Vehicle in the treatment of fungal infection of the outer ear…
- Trial name
- NCT04432376
- Testing
- miconazole 2% oil, vehicle oil
- Where
- 12 sites in United States
- Volunteers
- 382 people, healthy volunteers welcome
- Sponsor
- Hill Dermaceuticals, Inc.
Sensorineural Hearing Loss, Bilateral, Cochlear Implant
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
- Trial name
- NCT03304106
- Testing
- Commercially available cochlear implant and AI system
- Where
- 9 sites in United States
- Volunteers
- 102 people
- Sponsor
- Cochlear
Acute Otitis Media
Ear Drops for Children With Otitis Media
The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media.
- Trial name
- NCT00622518
- Testing
- Hyland's earache drops
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- University of Washington
Epilepsy; Seizure, Neuromuscular Diseases
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
The "North Carolina Clinical Genomic Evaluation by Next-gen Exome Sequencing, 2 (NCGENES 2)" study is part of a larger consortium project investigating the clinical utility, or net benefit of an intervention on patient and family…
- Conditions
- Epilepsy; Seizure, Neuromuscular Diseases, Brain Malformation, Intellectual Disability
- Trial name
- NCGENES2 (NCT03548779)
- Testing
- Pre-visit prep, usual care + exome seq
- Where
- 3 sites in United States
- Volunteers
- 548 people
- Sponsor
- University of North Carolina, Chapel Hill
Hearing Loss, Hearing Impaired Children
Audiobooks for Hearing Loss App as Auditory Training
The goal of the proposed project is to create an Audiobooks for Hearing Loss (HL) App - an audiobook App that has a wide array of user-selectable features designed to provide auditory training.
- Conditions
- Hearing Loss, Hearing Impaired Children, Hearing Impairment
- Trial name
- NCT04231396
- Testing
- Audiobooks for hearing loss App
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- BioSpeech
Hearing Loss
N6 Input Processing in Traditional CI Recipients
The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.
- Trial name
- NCT02239263
- Testing
- Nucleus 6 Sound Processor
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Cochlear
Acute Otitis Media
Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance
The investigators will study whether, in young children with acute otitis media (AOM), shortening length of antibiotic treatment as a strategy for reducing antimicrobial resistance provides satisfactory clinical outcome.
- Trial name
- NCT01511107
- Testing
- Amoxicillin-Clavulanate, 10 days, Amoxicillin-Clavulanate, 5 days
- Where
- 2 sites in United States
- Volunteers
- 520 people
- Sponsor
- Alejandro Hoberman
Cytomegalovirus Infection
Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss
This is an international, multi-center, double-blind, placebo-controlled evaluation valganciclovir treatment for up to 54 children (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss.
- Trial name
- NCT01649869
- Testing
- Valganciclovir
- Where
- 18 sites in United States, United Kingdom
- Volunteers
- 54 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Sensorineural Hearing Loss, Autoimmune Inner Ear Disease
A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED) that did not respond to oral steroid therapy…
- Trial name
- NCT01267994
- Testing
- Anakinra
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Andrea Vambutas
Metabolism, Inborn Errors, Hearing Loss
North Carolina Newborn Exome Sequencing for Universal Screening
The NC NEXUS research study is exploring the utility of next generation sequencing in newborn screening and parental decision making.
- Conditions
- Metabolism, Inborn Errors, Hearing Loss, Hereditary Disease
- Trial name
- NC_NEXUS (NCT02826694)
- Testing
- Well infant, whole exome sequencing, Diagnosed, whole exome sequencing
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Otitis Media
Singapore Tympanostomy Tube Delivery System Study
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis…
- Trial name
- NCT01046877
- Testing
- Tympanostomy Tube Delivery System
- Where
- Singapore
- Volunteers
- 25 people
- Sponsor
- Integra LifeSciences Corporation
Otitis Media
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear.
- Trial name
- NCT02600559
- Testing
- OTO-201 (ciprofloxacin)
- Where
- United States
- Volunteers
- 501 people
- Sponsor
- Otonomy, Inc.
Otitis Externa
Performance and Safety of Otinova® Ear Spray
The purpose of this study is to assess the performance and safety of Otinova® Ear Spray when used in the treatment of external otitis symptoms.
- Trial name
- NCT05370209
- Testing
- Otinova® Ear Spray
- Where
- 3 sites in Sweden
- Volunteers
- 28 people
- Sponsor
- Circius Pharma AB
Otitis Media With Effusion
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
- Trial name
- NCT01949155
- Testing
- OTO-201
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Otonomy, Inc.
Acute Otitis Externa, Swimmer's Ear
Phase 3 Study of OTO-201 in Acute Otitis Externa
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201…
- Trial name
- NCT02801370
- Testing
- 12 mg ciprofloxacin
- Where
- 2 sites in United States, Canada
- Volunteers
- 262 people
- Sponsor
- Otonomy, Inc.
Hearing Loss, Sensorineural
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
- Trial name
- SME (NCT03007472)
- Testing
- CI532, Nucleus 7
- Where
- 10 sites in United States
- Volunteers
- 96 people
- Sponsor
- Cochlear