## Protocol Section
### Identification Module
**NCT ID:** NCT06420921

**Acronym:** MIRACLE

**Brief Title:** MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

**Official Title:** MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

#### Organization Study ID Info
**ID:** 2023-153
#### Organization
**Class:** INDUSTRY
**Full Name:** Institut Pasteur
### Status Module
#### Completion Date
**Date:** 2026-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Institut de l'Audition

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Institut Pasteur

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this interventional study is to describe how people with cochlear implants perceive the perceive speech in noise and their sound environment on adults who are native French speakers with typical hearing or with cochlear implant(s).

The measures and strategies developed in this project could benefit all current and future cochlear implant wearers by improving their perception of the sound environment and their quality of life on a daily basis.

Researchers will compare normal hearing participant and participants with cochlear implant to describe the speech in noise and their perception of the sound environment.

Participants will perform audiological tests to assess their perception of the sound environment, with and without speech enhancement.

### Conditions Module

**Conditions:**

- Cochlear Hearing Loss

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Speech in noise comprehension test

- Behavioral: Objective tests of perception of ambient sound cues in noise

- Behavioral: Subjective tests of perception of ambient sound cues in noise

**Label:** Participants with cochlear implant

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Behavioral: Speech in noise comprehension test

- Behavioral: Objective tests of perception of ambient sound cues in noise

- Behavioral: Subjective tests of perception of ambient sound cues in noise

**Label:** Normal hearing participants

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Normal hearing participants

- Participants with cochlear implant

**Description:** Speech in noise comprehension tests consisting of listening to a speech source and one or more competing sources (noise, speech or sound cues) simultaneously. The volunteers will have to repeat the speech source in order to assess intelligibility for each situation, as a function of the intensity ratio of the two sources (SNR).

**Name:** Speech in noise comprehension test

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Normal hearing participants

- Participants with cochlear implant

**Description:** Tests of perception of the sound environment consisting of listening to a source of noise, sound cues and a competing source of speech simultaneously. The volunteers will have to identify sound cues in order to assess the ability to perceive the sound environment for each situation, depending on the intensity ratio of the different sources.

**Name:** Objective tests of perception of ambient sound cues in noise

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Normal hearing participants

- Participants with cochlear implant

**Description:** Tests of perception of the sound environment consisting of listening to a source of noise, sound cues and a competing source of speech simultaneously. Using a simple interface, the volunteers will have to identify the intensity ratio of the sources that they consider to be the best compromise between understanding speech and perceiving the sound environment.

**Name:** Subjective tests of perception of ambient sound cues in noise

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** percentage of environmental sound cues correctly identified when presented simultaneously with other signals

**Time Frame:** 2 years

#### Secondary Outcomes

**Measure:** comparison of the percentages of correctly identified environmental sound cues obtained objectively and deduced from the signal-to-noise ratio corresponding to the trade-off indicated by the participant

**Time Frame:** 2 years

**Measure:** the percentages of words correctly repeated by participants using non-personalised speech enhancement strategies

**Time Frame:** 2 years

**Measure:** percentages of words correctly repeated by participants using personalised speech enhancement strategies

**Time Frame:** 2 years

**Measure:** comparison of the percentages of correctly identified sound cues and the SNR corresponding to the subjective trade-off

**Time Frame:** 2 years

**Measure:** percentages of sound cues correctly identified by the participants using non-personalised speech enhancement strategies

**Time Frame:** 2 years

**Measure:** percentages of sound cues correctly identified by the participants using personalised speech enhancement strategies

**Time Frame:** 2 years

**Measure:** comparison of percentages of words correctly repeated

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

For all participants:

* 18 years of age or over,
* Native French speaker,
* Having given their consent to take part in the research.

For cochlear implant patients:

* Adult implanted and declaring that they have been using the implant for at least 18 months,
* Normal speech audiometry in silence

For controls reporting normal hearing:

* Normal tonal audiometry (defined as a mean tonal loss not exceeding 30 decibel (dB) HL)
* Normal speech audiometry in noise (SNR between -8 dB and -4dB inclusive)

Exclusion Criteria:

* Be under guardianship or curatorship,
* deprived of liberty by judicial or administrative decision, or subject to legal protection,
* Non- native French speaker.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clement.gaultier@pasteur.fr

**Name:** Clément Gaultier, PhD

**Phone:** 0176535126

**Phone Ext:** +33

**Role:** CONTACT

**Contact 2:**

**Email:** paul.avan@pasteur.fr

**Name:** Paul Avan, MD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Paris

**Country:** France

**Facility:** CEntre de Recherche et d'Innovation en Audiologie Humaine

**Zip:** 75015

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006311

- Term: Hearing Disorders

- ID: D000004427

- Term: Ear Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

- ID: D000012678

- Term: Sensation Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M24420

- Name: Hearing Loss

- Relevance: HIGH

- As Found: Hearing Loss

- ID: M6840

- Name: Deafness

- Relevance: LOW

- As Found: Unknown

- ID: M9407

- Name: Hearing Loss, Sensorineural

- Relevance: HIGH

- As Found: Cochlear Hearing Loss

- ID: M9400

- Name: Hearing Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7601

- Name: Ear Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15490

- Name: Sensation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000034381

- Term: Hearing Loss

- ID: D000006319

- Term: Hearing Loss, Sensorineural

### Misc Info Module

- Version Holder: 2024-05-31
