Severe to Profound Mixed Hearing LossNCT02156167

Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs

A study testing CP810 and Codacs™ system test in people with Severe to Profound Mixed Hearing Loss, run by Cochlear at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Severe to Profound Mixed Hearing Loss
What is being tested?: CP810 and Codacs™ system test
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteGermany
Study dates: Mar 2014to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subjects implanted with a Cochlear C-DACS investigational device

Who cannot join

Participation in another medical device study
Unwillingness or inability of the subject to comply with the study requirements

Trial locations and contacts

1 site in 1 country.

Germany1 site

Hannover Medical School
Hanover, Lower Saxony, 30625

Other trials in Germany

About this study

Official title: Clinical Validation of the Nucleus® CP810 Sound Processor for the Codacs™ System

The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech reception threshold in noise, to evaluate the usability of the Codacs™ Fitting Software, to evaluate the quality of life with the Nucleus® CP810 Sound Processor for the Codacs™ system, to collect long term data, to evaluate the acceptance criteria of the postoperative Codacs™ system test and to evaluate the usability of the Codacs™ Test System.

Conditions: Severe to Profound Mixed Hearing Loss
Being tested: CP810 and Codacs™ system test
Keywords: Otosclerosis, cochlear implant, acoustic stimulation
Medical subject headings: Otosclerosis

What participants receive

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

CP810 and Codacs™ system testDevice
Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)

Study groups in NCT02156167
Study group	Role	What they receive
CP810 and Codacs™Test System	Experimental	Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked) Receives: Device: CP810 and Codacs™ system test

What is being measured

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

Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test
The Oldenburger Sentence test is an adaptive speech in noise test with a fixed noise level of typically 65 decibel (dB) sound pressure level (SPL) and a varying speech level, depending on how many words in a sentence were repeated correctly by the subject. The outcome of this test is the signal-to-noise ratio (SNR) at which 50% of words in the sentence list were correctly repeated by the subject. The SRT in noise with the Freedom sound processor at the initial study visit was compared to the SRT in noise with the CP810 at the 3 months follow-up at different measurement conditions.
Speech and noise coming from the front (S0N0)- Speech coming from the front and noise coming from the implanted side (S0N90)- Everyday program (E): omnidirectional microphone- Noise program (N): directional microphone- Freedom Sound Processor (Freedom)- CP810 Sound Processor (CP810).
Measured: 3 months after initial upgraded fitting

Timeline

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

Mar 2014Jun 2015

First posted5 Jun 2014 (estimated)
Study startMar 2014
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Severe to Profound Mixed Hearing LossStudies of the same condition, open and under way.
More trials run by CochlearThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02156167
Sponsor's protocol ID: CEL5441
Status last verified: Jul 2015
First submitted: 3 Jun 2014
Last updated: 21 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lenarz T, Zwartenkot JW, Stieger C, Schwab B, Mylanus EA, Caversaccio M, Kompis M, Snik AF, D'hondt C, Mojallal H. Multicenter study with a direct acoustic cochlear implant. Otol Neurotol. 2013 Sep;34(7):1215-25. doi: 10.1097/MAO.0b013e318298aa76.
PubMed 23921930
Lenarz T, Verhaert N, Desloovere C, Desmet J, D'hondt C, Gonzalez JC, Kludt E, Macias AR, Skarzynski H, Van de Heyning P, Vyncke C, Wasowski A. A comparative study on speech in noise understanding with a direct acoustic cochlear implant in subjects with severe to profound mixed hearing loss. Audiol Neurootol. 2014;19(3):164-74. doi: 10.1159/000358004. Epub 2014 Feb 18.
PubMed 24556905

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Validation of the Nucleus® CP810 Sound Processor for the Codacs™ System
ClinicalTrials.gov ID: NCT02156167
Acronym / sponsor ID: CEL5441
Conditions: Severe to Profound Mixed Hearing Loss
Keywords: Otosclerosis, cochlear implant, acoustic stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: CochlearIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 5 Jun 2014 (estimated)
Results: Posted 21 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CP810 and Codacs™Test System	Experimental	Device: CP810 and Codacs™ system testNucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Subjects implanted with a Cochlear C-DACS investigational device

Key exclusion criteria (2 listed)

Participation in another medical device study
Unwillingness or inability of the subject to comply with the study requirements

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CP810 and Codacs™ system testNucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)	Device	CP810 and Codacs™Test System

Primary outcome

Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test
Time frame: 3 months after initial upgraded fitting
The Oldenburger Sentence test is an adaptive speech in noise test with a fixed noise level of typically 65 decibel (dB) sound pressure level (SPL) and a varying speech level, depending on how many words in a sentence were repeated correctly by the subject. The outcome of this test is the signal-to-noise ratio (SNR) at which 50% of words in the sentence list were correctly repeated by the subject. The SRT in noise with the Freedom sound processor at the initial study visit was compared to the SRT in noise with the CP810 at the 3 months follow-up at different measurement conditions. Speech and noise coming from the front (S0N0)- Speech coming from the front and noise coming from the implanted side (S0N90)- Everyday program (E): omnidirectional microphone- Noise program (N): directional microphone- Freedom Sound Processor (Freedom)- CP810 Sound Processor (CP810).

Results and safety

Results posted to the registry on 21 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CP810	15	15

Primary outcome: Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test

Time frame: 3 months after initial upgraded fitting. Mean (Standard Deviation). Unit: dB SNR

Measure	CP810 n = 13
S0N0 - E - Freedom	-0.83 (2.04)
S0N0 - E - CP810	-1.45 (2.29)
S0N90 - E - Freedom	0.64 (2.92)
S0N90 - E - CP810	0.89 (2.83)
S0N0 - N - CP810	-1.22 (1.69)
S0N90 - N - CP810	-3.78 (3.33)

Population analysed: One subject did not visit the clinic for the 3 months follow-up, a second subject did not perform the speech in noise test at the 3 months follow-up due to tiredness

Adverse events

Time frame: March 2014 to June 2015. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CP810	0 of 15 (0%)	0 of 15 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23921930Lenarz T, Zwartenkot JW, Stieger C, Schwab B, Mylanus EA, Caversaccio M, Kompis M, Snik AF, D'hondt C, Mojallal H. Multicenter study with a direct acoustic cochlear implant. Otol Neurotol. 2013 Sep;34(7):1215-25. doi: 10.1097/MAO.0b013e318298aa76.
Background: PubMed 24556905Lenarz T, Verhaert N, Desloovere C, Desmet J, D'hondt C, Gonzalez JC, Kludt E, Macias AR, Skarzynski H, Van de Heyning P, Vyncke C, Wasowski A. A comparative study on speech in noise understanding with a direct acoustic cochlear implant in subjects with severe to profound mixed hearing loss. Audiol Neurootol. 2014;19(3):164-74. doi: 10.1159/000358004. Epub 2014 Feb 18.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ernst von Wallenberg, PhD study director

Cochlear

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CP810 and Codacs™ system test in people with Severe to Profound Mixed Hearing Loss, run by Cochlear at 1 site in Germany.

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 1 inclusion and 2 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: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 21 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test (time frame: 3 months after initial upgraded fitting). 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 NCT02156167, which also lists 2 linked publications.

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 21 Jul 2016.