Spectral and temporal processing by prelingually deafened CI users.

Spectral and temporal processing by prelingually deafened adult CI users: Focus on electrode discrimination and amplitude modulation detection.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON19912

Enrollment

Registered

2012-05-15

Start date

2012-07-02

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

deafness, cochlear implant, prelingually deafened doofheid, cochleair implantaat, prelinguaal doof

Interventions

An intervention is only done in part 1B of the study. Parts 1A, 2A and 2B are observational cohort studies. The intervention in part 1B consists of an adaptation in the listening programme the subject

Eligibility

Inclusion criteria

Inclusion criteria: 1. Mother tongue Dutch; 2. Normal reading skills; 3. Oral communication as primary mode of communication; 4. Age at implantation >16 years; 5. Age at inclusion >18 years en < 80 years; 6. Onset of deafness before the age of 4; 7. Minimally 1 year experience with the CI. For part 1 of the study an additional exclusion criterion is: Implanted with a CI of the brand Cochlear. For part 2 of the study there is a second group of participants for whom the onset of deafness is after the age of 4 years.

Exclusion criteria

Exclusion criteria: There are no additional exclusion criteria.

Design outcomes

Primary

Measure	Time frame
For the listening task of part 1A the main study parameter is the electrode discrimination ability per electrode. The main study parameter of part 1B is the difference between subjects’ speech understanding with the standard and adapted speech programme. The main study parameters of the listening task of part 2 are the mean amplitude modulation detection thresholds of the prelingually and postlingually deafened CI-users.	—

Measure

Time frame

For the listening task of part 1A the main study parameter is the electrode discrimination ability per electrode. The main study parameter of part 1B is the difference between subjects’ speech understanding with the standard and adapted speech programme. The main study parameters of the listening task of part 2 are the mean amplitude modulation detection thresholds of the prelingually and postlingually deafened CI-users.

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Secondary

Measure	Time frame
If a SADE (Serious Adverse Device Effect) would occur, causing tissue damage or serious discomfort/distress to the subject, this implies the end of the study for this subject. This is mainly applicable for part 1A, since in part 1B and part 2 no additional medical device (different from the patients’ own clinical device) is used. However, if any other SAE occurs, not related to the use of the medical device, this also indicates the end of the study for this subject.	—

Measure

Time frame

If a SADE (Serious Adverse Device Effect) would occur, causing tissue damage or serious discomfort/distress to the subject, this implies the end of the study for this subject. This is mainly applicable for part 1A, since in part 1B and part 2 no additional medical device (different from the patients’ own clinical device) is used. However, if any other SAE occurs, not related to the use of the medical device, this also indicates the end of the study for this subject.

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Contacts

Public ContactJoke Debruyne

Postbus 5800

joke.debruyne@mumc.nl+31 (0)433 874594

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)