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CompletedNCT05237180CAudiBruitUpdated Oct 20, 2022

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

An interventional study of spatial localisation training in Hearing Loss, Cochlear, sponsored by Centre Hospitalier Universitaire de la Réunion. Completed at 1 site in Réunion. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-10-20.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hearing Loss, Cochlear
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 12 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 137 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • do not realize speech reeducation (spatial localisation and speech perception) during the study
  • no change in setting of cochlear implants
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    patient group

    8 training sessions on spatial localisation

    Other: spatial localisation training

  • No intervention
    control croup

    Non training sessions

Interventions

  • Otherspatial localisation training

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 weeks after inclusion

  2. 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.

    Time frame: 10 weeks after inclusion

07

Study locations

1 site
  • Gcs Crcsi
    Sainte Clotilde, Réunion
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05237180
Lead sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible party
Sponsor
First posted
Feb 14, 2022
Start date
Feb 15, 2022
Primary completion
Mar 1, 2022
Completion
Mar 1, 2022
Last update
Oct 20, 2022

Study contacts

Justine MAISSON
principal investigator · GCS CRCSI

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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