Longitudinal Study of the Natural History of Two Autosomal Recessive Non Syndromic Deafness (DFNB1A and DFNB9) in Children up to 16 Years of Age
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 16
Healthy Volunteers: f
View:
• Aged ≤ 16 years on the date of signed informed consent for cohort 1 and ≤ 10 years for cohort 2;
• With a diagnosis of non-syndromic, bilateral, mild to profound, sensorineural hearing loss (according to the American Speech Language-Hearing Association);
• With documented genotyping results showing mutation(s) in GJB2 or OTOF genes;
• Written informed consent as required by local regulations.
• Either without Cochlear Implant, or with unilateral or bilateral Cochlear Implant(s)
Locations
Other Locations
France
Necker Hospital
RECRUITING
Paris
Contact Information
Primary
Lionel HOVSEPIAN, MD
lionel.hovsepian@sensorion-pharma.com
+33 (0)7 86 31 13 76
Time Frame
Start Date: 2022-11-18
Estimated Completion Date: 2031-06
Participants
Target number of participants: 180
Treatments
Cohort 1a
Patients without Cochlear Implant, with or without Hearing Aid(s) at study entry
Cohort 1b
Patients receiving unilateral or bilateral Cochlear Implant(s) during the study period, after study entry
Cohort 2
Patients with Cochlear Implant(s) (unilateral or bilateral) at study entry
Related Therapeutic Areas
Sponsors
Leads: Sensorion