Hearing Loss, CochlearCMVPNCT04724265
Cytomegalovirus (CMV) Perilymphatic Fluid
A study testing collection of sample of perilymphatic fluid during cochlear implantation in people with Hearing Loss, Cochlear and Cytomegalovirus Congenital, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In France, children cochlear implantation (CI) is performed 400 times per year. Causes of profound sensorineural hearing loss (SNHL) are represented by congenital malformation of the inner ear for 50 to 60%. Most of the remaining cases of CI in children are caused by congenital CMV infection. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Hearing Loss, Cochlear, Cytomegalovirus Congenital
- What is being tested?
- collection of sample of perilymphatic fluid during cochlear implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2020to 10 Dec 2022
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children (under 18-year-old) presenting with a Sensorineural Hearing Loss with an indication of cochlear implantation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Robert Debré Hospital
Paris, 75019
Natacha TEISSIER, MD-PhD, +33140035367, natacha.teissier@aphp.fr
Thierry VAN DEN ABBEELE, MD-PhD, +33140032449, thierry.van-den-abbeele@aphp.fr
About this study
Official title: Cytomegalovirus in Perilymphatic Fluid During Cochlear Implantation of Children Presenting a Sensorineural Hearing Loss
In France, children cochlear implantation (CI) is performed 400 times per year. Causes of profound sensorineural hearing loss (SNHL) are represented by congenital malformation of the inner ear for 50 to 60%. Most of the remaining cases of CI in children are caused by congenital CMV infection. The proportion of CMV inducing SNHL with a CI in children is not clearly defined. During CI, we aim to collect a very small sample of perilymphatic fluid and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in SNHL.
Read the detailed description
Data on etiology of hearing loss and CMV status are collected. Perilymphatic liquid is collected after cochleostomy using a 1ml seringue. The drop of liquid is deposited on a Guthrie card; on another card, a drop of blood is deposited on another card. CMV PCR (polymerised chain reaction) is then performed in order to assess for the presence of CMV. The sensibility, specificity, positive and negative positive values are then calculated.
- Conditions
- Hearing Loss, Cochlear, Cytomegalovirus Congenital
- Being tested
- collection of sample of perilymphatic fluid during cochlear implantation
- Medical subject headings
- Hearing Loss, Sensorineural, Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of sample of perilymphatic fluid during cochlear implantationBiological
Also called collection of perilymphatic fluid
collection of sample of perilymphatic fluid during cochlear implantation and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in hearing loss.
| Study group | Role | What they receive |
|---|---|---|
| collection of sample of perilymphatic fluid during cochlear implantation | Experimental | collection of sample of perilymphatic fluid during cochlear implantation Receives: Biological: collection of sample of perilymphatic fluid during cochlear implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of CMV PCR in perilymphatic fluid
CMV PCR in perilymphatic fluid
Measured: 7 days after the collection of the sample (biological collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start10 Dec 2020
- Primary completion10 Dec 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, CochlearStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724265
- Sponsor's protocol ID
- APHP191072
- Acronym
- CMVP
- Status last verified
- Apr 2022
- First submitted
- 24 Jan 2021
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chebib E, Vauloup-Fellous C, Benoit C, Noel Petroff N, Van Den Abbeele T, Maudoux A, Teissier N. Is CMV PCR of inner ear fluid during cochlear implantation a way to diagnose CMV-related hearing loss? Eur J Pediatr. 2023 Jan;182(1):375-383. doi: 10.1007/s00431-022-04691-6. Epub 2022 Nov 12.
PubMed 36369401
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytomegalovirus in Perilymphatic Fluid During Cochlear Implantation of Children Presenting a Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT04724265
- Acronym / sponsor ID
- CMVP / APHP191072
- Conditions
- Hearing Loss, Cochlear, Cytomegalovirus Congenital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In France, children cochlear implantation (CI) is performed 400 times per year. Causes of profound sensorineural hearing loss (SNHL) are represented by congenital malformation of the inner ear for 50 to 60%. Most of the remaining cases of CI in children are caused by congenital CMV infection. The proportion of CMV inducing SNHL with a CI in children is not clearly defined. During CI, we aim to collect a very small sample of perilymphatic fluid and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in SNHL.
Detailed description
Data on etiology of hearing loss and CMV status are collected. Perilymphatic liquid is collected after cochleostomy using a 1ml seringue. The drop of liquid is deposited on a Guthrie card; on another card, a drop of blood is deposited on another card. CMV PCR (polymerised chain reaction) is then performed in order to assess for the presence of CMV. The sensibility, specificity, positive and negative positive values are then calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| collection of sample of perilymphatic fluid during cochlear implantation | Experimental | Biological: collection of sample of perilymphatic fluid during cochlear implantationcollection of sample of perilymphatic fluid during cochlear implantation |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children (under 18-year-old) presenting with a Sensorineural Hearing Loss with an indication of cochlear implantation
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| collection of sample of perilymphatic fluid during cochlear implantationAlso: collection of perilymphatic fluidcollection of sample of perilymphatic fluid during cochlear implantation and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in hearing loss. | Biological | collection of sample of perilymphatic fluid during cochlear implantation |
Primary outcome
Sensitivity and specificity of CMV PCR in perilymphatic fluid
Time frame: 7 days after the collection of the sample (biological collection)
CMV PCR in perilymphatic fluid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Derived from this study: PubMed 36369401Chebib E, Vauloup-Fellous C, Benoit C, Noel Petroff N, Van Den Abbeele T, Maudoux A, Teissier N. Is CMV PCR of inner ear fluid during cochlear implantation a way to diagnose CMV-related hearing loss? Eur J Pediatr. 2023 Jan;182(1):375-383. doi: 10.1007/s00431-022-04691-6. Epub 2022 Nov 12.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collection of sample of perilymphatic fluid during cochlear implantation in people with Hearing Loss, Cochlear and Cytomegalovirus Congenital, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 18 Apr 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natacha TEISSIER, MD PhD (+331.40.03.53.67, natacha.teissier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of CMV PCR in perilymphatic fluid (time frame: 7 days after the collection of the sample (biological collection)). 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 NCT04724265, which also lists 1 linked publication.
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 18 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.