Hearing Loss, CochlearCAudiBruitNCT05237180
Evaluation of the Effect of a Spatial Localization Training Program on Auditory Comprehension
A study testing spatial localisation training in people with Hearing Loss, Cochlear, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
Hearing comprehension under complex listening conditions is considered to be the central complaint of everyday life for patients with cochlear implants. Localization is one of the cues for listening comprehension. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hearing Loss, Cochlear
- What is being tested?
- spatial localisation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteReunion
- Study dates
- 15 Feb 2022to 1 Mar 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- post-lingual deafness
- implanted bilaterally for at least 1 year
- score ≥ 70 at LAFON scale
- score ≥ 70 at MBAA scale
- score ≥ 5/9 at CAP scale
- good command of the French language
- accepts to participate in the study
Who cannot join
- do not realize speech reeducation (spatial localisation and speech perception) during the study
- no change in setting of cochlear implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of a Spatial Localization Training Program on Auditory Comprehension in Noise in Bi-implanted Subjects With Post-lingual Deafness
Hearing comprehension under complex listening conditions is considered to be the central complaint of everyday life for patients with cochlear implants. Localization is one of the cues for listening comprehension. However, only few studies have investigated the effect of spatial localization training on listening comprehension performance in noise. None of these studies correspond to the desire to purpose training by speech therapists while using affordable equipment.
The main objective of this study is to evaluate the effect of a spatial localization training protocol in cochlear bi-implanted subjects with post-lingual deafness on their ability to understand in noise.
Read more
2 groups of 10 subjects each will be recruited: a patient group and a control group. The patient group will undergo 8 sessions of spatial localization rehabilitation lasting an average of 45 minutes each.
After this programme, the pre-test and post- test results obtained will be compared.
- Conditions
- Hearing Loss, Cochlear
- Being tested
- spatial localisation training
- 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.
spatial localisation trainingOther
8 spatial localization training sessions MBAA and SSQ tests before and after training sessions.
| Study group | Role | What they receive |
|---|---|---|
| patient group | Experimental | 8 training sessions on spatial localisation Receives: Other: spatial localisation training |
| control croup | No intervention | Non training sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Hearing comprehension performance in noise
MBAA (Marginal Benefic from Acoustical Amplification) scale. Minimal score = 0 and maximal score =540. minimum score means that the patient is unable to repeat phrases and maximal score means that the patient is able to repeats all phrases.
Measured: 10 weeks after inclusion
Change of Hearing comprehension performance in noise
15iSSQ (New 15 items Speech Spatial and qualities of hearing Scale Shoirt Form). Minimum score =0 and maximal score = 150. maximal score means that the patient has a good quality of life and minimum score means that his quality of life is bad.
It is a qualitative evaluation.
Measured: 10 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start15 Feb 2022
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, CochlearStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justine MAISSON, Principal investigator, GCS CRCSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237180
- Sponsor's protocol ID
- 2021/CHU/32
- Acronym
- CAudiBruit
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Spatial Localization Training Program on Auditory Comprehension in Noise in Bi-implanted Subjects With Post-lingual Deafness
- ClinicalTrials.gov ID
- NCT05237180
- Acronym / sponsor ID
- CAudiBruit / 2021/CHU/32
- Conditions
- Hearing Loss, Cochlear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 14 Feb 2022 (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.
Hearing comprehension under complex listening conditions is considered to be the central complaint of everyday life for patients with cochlear implants. Localization is one of the cues for listening comprehension. However, only few studies have investigated the effect of spatial localization training on listening comprehension performance in noise. None of these studies correspond to the desire to purpose training by speech therapists while using affordable equipment.
The main objective of this study is to evaluate the effect of a spatial localization training protocol in cochlear bi-implanted subjects with post-lingual deafness on their ability to understand in noise.
2 groups of 10 subjects each will be recruited: a patient group and a control group. The patient group will undergo 8 sessions of spatial localization rehabilitation lasting an average of 45 minutes each.
After this programme, the pre-test and post- test results obtained will be compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | Experimental | Other: spatial localisation training8 training sessions on spatial localisation |
| control croup | No intervention | –Non training sessions |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- post-lingual deafness
- implanted bilaterally for at least 1 year
- score ≥ 70 at LAFON scale
- score ≥ 70 at MBAA scale
- score ≥ 5/9 at CAP scale
Key exclusion criteria (2 listed)
- do not realize speech reeducation (spatial localisation and speech perception) during the study
- no change in setting of cochlear implants
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 |
|---|---|---|
| spatial localisation training8 spatial localization training sessions MBAA and SSQ tests before and after training sessions. | Other | patient group |
Primary outcome
Change of Hearing comprehension performance in noise
Time frame: 10 weeks after inclusion
MBAA (Marginal Benefic from Acoustical Amplification) scale. Minimal score = 0 and maximal score =540. minimum score means that the patient is unable to repeat phrases and maximal score means that the patient is able to repeats all phrases.
Change of Hearing comprehension performance in noise
Time frame: 10 weeks after inclusion
15iSSQ (New 15 items Speech Spatial and qualities of hearing Scale Shoirt Form). Minimum score =0 and maximal score = 150. maximal score means that the patient has a good quality of life and minimum score means that his quality of life is bad. It is a qualitative evaluation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Cochlear
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
Not yet recruiting
Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
Not yet recruitingPhase 1/2
A Study Testing Safety and Efficacy of Transtympanic Paliroden for the Treatment of Cochlear Synaptopathy in Participants With Chronic, Constant Tinnitus
Tinnitus, Bilateral, Cochlear Synaptopathy
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.
Justine MAISSON principal investigator
GCS CRCSI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spatial localisation training in people with Hearing Loss, Cochlear, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 7 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 20 Oct 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 Reunion. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of Hearing comprehension performance in noise (time frame: 10 weeks after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2022; AzTrials last refreshed its copy on 28 Oct 2026.