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A cohort study on the effect of acoustic nerve structural variation on postoperative auditory reconstruction in children with artificial auditory brainstem implantation

A bidirectional cohort study of the effect of acoustic nerve and other structural variations on postoperative auditory reconstruction in children with artificial auditory brainstem implantation

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100048681
Enrollment
Unknown
Registered
2021-07-12
Start date
2021-07-15
Completion date
Unknown
Last updated
2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensorineural Hearing Loss

Interventions

Normal auditory nerve structure group:None
Auditory nerve dysplasia group:None
Absence of auditory nerve structure group:None

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.From January 2019 to December 31, 2021, patients who have been performed auditory brainstem implantation in our center; 2.Patients can be regularly followed up in our department, and after surgery less than 30 months; 3.Patients with complete clinical data before enrollment; 4.Patients who have the conditions for auditory and speech rehabilitation; 5.Congenital deafness; 6.<=18 years old.

Exclusion criteria

Exclusion criteria: 1.Patients with other diseases which could affect the rehabilitation effect, such as autism, intellectual disability, etc.; 2.Deafness caused by tumor; 3.With important missing of clinical data.

Design outcomes

Primary

MeasureTime frame
Categories of auditory performance;Average pure pitch;Infant and Child Meaningful Hearing Integration Scale;

Secondary

MeasureTime frame
Speech function (Speech Intelligibility Rating);Speech function (Meaningful Speech Use Scale Rating);Speech function (putonghua early speech perception test);Electrode array status (the number of effective electrodes);Electrode array status (impedance);Electrode array status (Threshold);Electrode array status (loading capacity);

Countries

China

Contacts

Public ContactJia Huan, Wu Hao

Department of Otolaryngology Head and Neck Surgery, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

huan_jia_orl@163.com+86 13601797481

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026