Evaluation of the Effect of a Spatial Localization Training Program on Auditory Comprehension

NCT ID: NCT05237180

Last Updated: 2022-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2022-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Loss, Cochlear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patient group

8 training sessions on spatial localisation

Group Type EXPERIMENTAL

spatial localisation training

Intervention Type OTHER

8 spatial localization training sessions MBAA and SSQ tests before and after training sessions.

control croup

Non training sessions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

spatial localisation training

8 spatial localization training sessions MBAA and SSQ tests before and after training sessions.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* do not realize speech reeducation (spatial localisation and speech perception) during the study
* no change in setting of cochlear implants
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Justine MAISSON

Role: PRINCIPAL_INVESTIGATOR

GCS CRCSI

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gcs Crcsi

Sainte-Clotilde, , Reunion

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Reunion

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021/CHU/32

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.