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Hearing Loss, CochlearAPPICNCT04357704

Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlear Implant User.

A study testing S0N0, S0N500 and S-500N500 in people with Hearing Loss, Cochlear, run by Oticon Medical.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The aim of the study is to evaluate the interaural time difference (ITD) benefit in patients with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hearing Loss, Cochlear
What is being tested?
S0N0, S0N500 and S-500N500
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Apr 2019to 1 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Fluent in local language
  • Normal hearing listener:
  • pure tone threshold > 25dB from 125Hz to 12kHz
  • Cochlear implant recipient
  • bilaterally implanted 6 months at least, the second implant should be implanted 6 months at least before participant inclusion
  • Digisonic SP® cochlear implants user

Who cannot join

  • binaural sensitivity threshold < 1000µs

About this study

The aim of the study is to evaluate the interaural time difference (ITD) benefit in patients with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners. Half of participants are bilateral cochlear implants users, while the other are normal hearing listeners.

Read the detailed description

Listening in noisy environments is part of everyday life, it is based on binaural phenomena such as spatial localization.

Being tested
S0N0, S0N500, S-500N500, S0N1000, S0Nuncorr
Keywords
Iteraural Time Difference
Medical subject headings
Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S0N0Other

    (no ITD)

  • S0N500Other

    (ITD +500µs on noise)

  • S-500N500Other

    (ITD -500µs on signal and +500 µs on noise)

  • S0N1000Other

    (ITD + 1000 µs on noise)

  • S0NuncorrOther

    (no ITD cue, with uncorrelated stimulation frame)

Study groups in NCT04357704
Study groupRoleWhat they receive
bilateral cochlear implant recipientsExperimentalNot described
Receives: Other: S0N0; Other: S0N500; Other: S-500N500; Other: S0N1000; Other: S0Nuncorr
normal hearing listnersActive comparatorNot described
Receives: Other: S0N0; Other: S0N500; Other: S-500N500; Other: S0N1000; Other: S0Nuncorr

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue

    SRT is used as an outcome measure to quantify the acuity for speech perception in noise with Interaural Time Difference between the two ears. Signal recognition in a background noise is assessed the following conditions S0N0, S0N500, S0N1000, S-500N500 et S0Nuncorr. The noise level is constant at 65 dB SPL, the signal level is modified in the adaptive procedure in order to converge towards a score of 50% of correct response.

    Measured: day 0

Secondary outcomes (3)

  1. speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners

    SRT is used as an outcome measure to quantify the acuity for speech perception in noise without Interaural Time Difference between the two ears.

    Measured: day 0

  2. ITD sensitivity in bilateral cochlear implant user

    Speech signal and noise are presented at 65dB SPL. Participant adjusts the Interaural Time Difference between the speech signal and noise between -1000 and +1000µs. Participant moves the cursor on the interface until he/she hears a difference in sound.

    Measured: day 0

  3. Preferred jitter in bilateral cochlear implant user

    Speech signal and noise are presented at 65dB SPL. Participant adjusts the jitter of the train pulse timing from 0 to +1000µs to improve the Interaural Time Difference.

    Measured: day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2020
  2. Study start1 Apr 2019 (estimated)
  3. Primary completion1 Jun 2019 (estimated)
  4. Study completion1 Sep 2019 (estimated)

Why it stopped: Delay in setting up the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04357704
Sponsor's protocol ID
PIC_10
Acronym
APPIC
Status last verified
Jul 2025
First submitted
27 Nov 2018
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing S0N0, S0N500 and S-500N500 in people with Hearing Loss, Cochlear, run by Oticon Medical.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue (time frame: day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04357704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.

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