Clinical trials: Hearing Disorders in Children
Hearing Loss
Bilateral Cochlear Implant Benefit in Young Children
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in…
- Trial name
- NCT00424307
- Testing
- HiResolution Bionic Ear System
- Where
- 14 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Advanced Bionics
Hearing Loss, Unilateral, Deafness, Unilateral
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for…
- Trial name
- PAS-SSD (NCT05318417)
- Testing
- The Cochlear™ Nucleus® Cochlear Implant (CI) System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cochlear
Hearing Loss, Conductive, Hearing Loss, Mixed
Pediatric Expansion Study of the Sentio System
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Single Sided Deafness
- Trial name
- BC119 (NCT06976086)
- Testing
- Active transcutaneous bone conduction system
- Where
- 8 sites in Netherlands, Spain and 1 more
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
Migraine
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine.
- Trial name
- NCT05156398
- Testing
- Rimegepant
- Where
- 93 sites in United States, Canada and 5 more
- Volunteers
- 640 people
- Sponsor
- Pfizer
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
Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma
A Compassionate Use Program to Provide Access to Sodium Thiosulfate
This is a CUP which is designed to provide treatment access of STS to pediatric patients for the protection from Cisplatin-Induced Hearing Loss in children who had standard-risk hepatoblastoma.
- Trial name
- NCT04132882
- Testing
- Sodium Thiosulfate (STS)
- Where
- Turkey (Türkiye)
- Sponsor
- TRPHARM
Acute Treatment of Migraine
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to < 18 years of age).
- Trial name
- NCT04743141
- Testing
- Rimegepant (PF-07899801)
- Where
- 124 sites in United States, Poland and 1 more
- Volunteers
- 600 people
- Sponsor
- Pfizer
Congenital Heart Disease
A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.
- Trial name
- NCT00538785
- Testing
- Motavizumab, Palivizumab
- Where
- 152 sites in United States, Austria and 15 more
- Volunteers
- 1,236 people
- Sponsor
- MedImmune LLC
OTOF Gene Mutation, DFNB9
A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.
- Conditions
- OTOF Gene Mutation, DFNB9, Congenital Deafness, Hearing Disorders
- Trial name
- AUDIOGENE (NCT06370351)
- Testing
- SENS-501 administration
- Where
- 2 sites in Australia, France
- Volunteers
- 12 people
- Sponsor
- Sensorion
Speech Perception
Improving Perception of Speech in Noise in Children With Communication Disorders
Smarty Ears has developed a prototype of an innovative therapeutic training system to improve speech perception in noise by training children on interrupted noise (which has silent intervals that allow for fragments of the target…
- Trial name
- L2F (NCT04473729)
- Testing
- Audiovisual speech training in noise for children
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Smarty Ears
Hearing Loss, Conductive
Evaluation of the BHX Implant in Children with a BAHS
The purpose of this study is to in a proactive manner collect high quality data from pediatric patients who have undergone a bone anchored hearing surgery, using the Ponto BHX implant, in clinical practice.
- Trial name
- NCT03742089
- Testing
- Bone Anchored Hearing Surgery
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Oticon Medical
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Optimizing Soft Speech Recognition in Children With Hearing Loss
Overhearing is important for vocabulary learning and speech and language development in young children. However, contemporary hearing aids are generally unable to provide adequate access to low-level auditory inputs from multiple…
- Trial name
- SoftSpeech (NCT05299892)
- Testing
- Phonak Audeo P or Naida P hearing aid
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Sonova AG
Pediatric Migraine
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
- Trial name
- NCT04649242
- Testing
- Rimegepant/BHV3000
- Where
- 246 sites in United States, Canada and 7 more
- Volunteers
- 2,100 people
- Sponsor
- Pfizer
Sensorineural Hearing Loss, Bilateral, AUNB1
Natural History in Children up to 16 Years With Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes
The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (GJB2 or OTOF) in children up to 16 years of age.
- Conditions
- Sensorineural Hearing Loss, Bilateral, AUNB1, DFNB1A, Congenital Deafness
- Trial name
- Otoconex (NCT05402813)
- Testing
- Pure Tone Audiometry Assessment, Quality of Life Questionnaires
- Where
- France
- Volunteers
- 180 people
- Sponsor
- Sensorion
Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF), Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene
A Natural History Study in Pediatric Participants With Hearing Loss Due to OTOF, GJB2, or GJB2/GJB6 Mutations
This is an observational study to examine the characteristics of gene-related hearing loss in pediatric participants with biallelic otoferlin (OTOF) Mutations, Gap Junction Beta 2 (GJB2) Mutations, or Digenic GJB2/Gap Junction…
- Conditions
- Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF), Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene, Digenic Mutations in GJB2/Gap Junction Beta 6 (GJB6) Genes
- Trial name
- ENSEMBLE (NCT06019481)
- Where
- 2 sites in United States
- Sponsor
- Regeneron Pharmaceuticals
Hearing Loss
Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant
The purpose of this study is to evaluate and document longitudinal efficacy in young children implanted bilaterally with MED-EL COMBI 40+ / PULSARCI100/SONATATI100 cochlear implant systems.
- Trial name
- NCT00784043
- Testing
- Cochlear Implant
- Where
- 9 sites in United States, Canada
- Volunteers
- 37 people
- Sponsor
- Med-El Corporation
Hearing Loss, Conductive, Hearing Loss, Mixed
Evaluating the Safety of BONEBRIDGE Implants in Children Under Five Years Old: This Study Looks at Children Under Five Who Got BONEBRIDGE BCI 602 Implants. It Collects Information on Any Problems With the Device or the Surgery to See if it is Safe Within the First Year After the Operation.
This study, titled "The BONEBRIDGE in Children Under Five: Premarket Clinical Investigation" (Study ID 2023BB006), looks at kids under five who have received the BONEBRIDGE BCI 602 hearing implant.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Children Under 5 Years
- Trial name
- 2023BB006 (NCT06634784)
- Testing
- Bone Conduction Implant (BCI)
- Where
- 2 sites in Germany
- Volunteers
- 9 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations
Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat pediatric and adult participants who have severe-to profound and profound hearing loss due to…
- Trial name
- CHORD (NCT05788536)
- Testing
- DB-OTO
- Where
- 17 sites in United States, Germany and 3 more
- Volunteers
- 36 people
- Sponsor
- Regeneron Pharmaceuticals