## Protocol Section
### Identification Module
**NCT ID:** NCT06420037

**Brief Title:** The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings

**Official Title:** The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings

#### Organization Study ID Info
**ID:** ONZ-2023-0437
#### Organization
**Class:** OTHER
**Full Name:** University Ghent
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Ghent

#### 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 clinical trial is to optimize hearing aid benefit based on the individual auditory-cognitive need using different hearing aid features in first-time hearing aid users between 45-80 years old with bilateral Phonak Audéo Paradise/Lumity 70 hearing aids. The main questions it aims to answer are:

Does cognitive functioning affect hearing aid benefit? How can hearing aid fitting be optimized based on the individual auditory-cognitive profile?

The hypothesis posits that cognitive abilities influence the effectiveness of hearing aids, alongside hearing status. Furthermore, if features of hearing aids improve speech understanding and listening effort, it is proposed that individuals with lower cognitive functioning will experience heightened benefits from hearing aids.

The study will consist of three groups: one control group and two groups where one different feature will be modified.

Participants will be tested at baseline measurement, including:

* screening tests
* audiological tests
* questionnaires
* cognitive tests
* real-ear-measurement

Following this, participants will be divided in one of the three groups, after which speech audiometry will be repeated. After a 4-week acclimatization period, the second measurement will take place, repeating speech audiometry and questionnaires. Subsequently, the hearing aid settings will be restored to their initial configuration.

### Conditions Module

**Conditions:**

- Speech Intelligibility

- Hearing Loss, Sensorineural

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Within this control group, no changes will be made to the hearing aid settings. However, they undergo all other tests of the test protocol.

**Intervention Names:**

- Behavioral: Cognitive screening and vision screening

- Behavioral: Audiological Assessment

- Behavioral: Questionnaires

- Behavioral: Cognition

- Other: Real ear measurement

**Label:** Individuals between 45-80 years with bilateral hearing aids (control group)

**Type:** OTHER

#### Arm Group 2

**Description:** Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting.

**Intervention Names:**

- Device: Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70

- Behavioral: Cognitive screening and vision screening

- Behavioral: Audiological Assessment

- Behavioral: Questionnaires

- Behavioral: Cognition

- Other: Real ear measurement

**Label:** Individuals between 45-80 years with bilateral hearing aids (frequency compression)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting.

**Intervention Names:**

- Device: Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70

- Behavioral: Cognitive screening and vision screening

- Behavioral: Audiological Assessment

- Behavioral: Questionnaires

- Behavioral: Cognition

- Other: Real ear measurement

**Label:** Individuals between 45-80 years with bilateral hearing aids (noise reduction)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Individuals between 45-80 years with bilateral hearing aids (frequency compression)

**Description:** Upon enrollment, each participant will be allocated to one of three research groups and participants will remain unaware of their group assignment. This groups will undergo a slight modification, namely frequency compression turned off, to the basic setting.

**Name:** Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Individuals between 45-80 years with bilateral hearing aids (noise reduction)

**Description:** Upon enrollment, each participant will be allocated to one of three research groups and participants will remain unaware of their group assignment. This groups will undergo a slight modification, namely noise reduction turned off, to the basic setting.

**Name:** Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- Individuals between 45-80 years with bilateral hearing aids (control group)

- Individuals between 45-80 years with bilateral hearing aids (frequency compression)

- Individuals between 45-80 years with bilateral hearing aids (noise reduction)

**Description:** The Dutch Montreal Cognitive Assessment will be assessed. The Snellen Eye Test will be used to screen for normal or corrected-to-normal vision.

**Name:** Cognitive screening and vision screening

**Type:** BEHAVIORAL

#### Intervention 4

**Arm Group Labels:**

- Individuals between 45-80 years with bilateral hearing aids (control group)

- Individuals between 45-80 years with bilateral hearing aids (frequency compression)

- Individuals between 45-80 years with bilateral hearing aids (noise reduction)

**Description:** Three audiological tests are included: 1) Tympanometry to assess the middle ear status, 2) Pure-tone audiometry with headphone to evaluate the hearing thresholds, 3) Speech audiometry in free field to assess the ability to understand spoken sentences in quiet and in the presence of background noise.

**Name:** Audiological Assessment

**Type:** BEHAVIORAL

#### Intervention 5

**Arm Group Labels:**

- Individuals between 45-80 years with bilateral hearing aids (control group)

- Individuals between 45-80 years with bilateral hearing aids (frequency compression)

- Individuals between 45-80 years with bilateral hearing aids (noise reduction)

**Description:** Three questionnaires are included:

1. The HAVICOP questionnaire to assess the hearing-related quality of life (Ceuleers, D., Baudonck, N., Keppler, H., Kestens, K., Dhooge, I., \& Degeest, S. (2023). Development of the hearing-related quality of life questionnaire for auditory-visual, cognitive and psychosocial functioning (hAVICOP). Journal of communication disorders, 101, 106291.)
2. the FAS (fatigue assessment scale) to assess how you usually feel
3. the EEAS (extended effort assessment scale) to assess how you experience listening in everyday life.

**Name:** Questionnaires

**Type:** BEHAVIORAL

#### Intervention 6

**Arm Group Labels:**

- Individuals between 45-80 years with bilateral hearing aids (control group)

- Individuals between 45-80 years with bilateral hearing aids (frequency compression)

- Individuals between 45-80 years with bilateral hearing aids (noise reduction)

**Description:** Four cognitive functions, important for speech understanding, will be assessed both audibly and visually: divided attention, working memory, processing speed, and cognitive flexibility and inhibition.

**Name:** Cognition

**Type:** BEHAVIORAL

#### Intervention 7

**Arm Group Labels:**

- Individuals between 45-80 years with bilateral hearing aids (control group)

- Individuals between 45-80 years with bilateral hearing aids (frequency compression)

- Individuals between 45-80 years with bilateral hearing aids (noise reduction)

**Description:** This test will give an objective assessment of the hearing aids' configuration.

**Name:** Real ear measurement

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Based on the results of the speech understanding task, the speech reception threshold will give an indication of the ability to understand spoken sentences in quiet and noise.

**Measure:** Speech reception threshold

**Time Frame:** This outcome measure will be assessed twice during the initial measurement (both +/- 10 minutes) and once during the second measurement (+/- 10 minutes).

#### Secondary Outcomes

**Description:** Thirty-five sentences should be responded using a VAS (0-100). Mean scores will be calculated for each subdomain separately (auditory-visual, cognitive, and psychosocial functioning) as well as combined within a total score; the worse one's hearing-related quality of life, the lower the score.

**Measure:** Hearing related quality of life

**Time Frame:** This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 10 minutes).

**Description:** Ten sentences should be responded based on five categories, ranging from Never to Always: 1 = Never; 2 = Sometimes; 3 = Frequently; 4 = Often; and 5 = Always.

**Measure:** Fatigue assessment

**Time Frame:** This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).

**Description:** Ten sentences should be responded using a VAS (0-100). Mean scores will be calculated for each sentence. The lower the score, the lower the effort.

**Measure:** Effort assessment

**Time Frame:** This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).

**Description:** Cognitive functions such as 'divided attention', 'working memory', 'processing speed', and 'flexibility and inhibition' will be assessed both audibly and visually. Mean scores and average reaction times will be computed.

**Measure:** Cognitive functioning (auditory and visual)

**Time Frame:** These outcome measures will be assessed once during the first measurement (+/- 55 minutes).

**Description:** Test to obtain an objective understanding of the current settings of the hearing aids.

**Measure:** Real ear measurement

**Time Frame:** This outcome measure will be assessed once during the first measurement (+/- 15-20 minutes).

**Description:** The result (max 30) on the MoCA will be calculated.

**Measure:** Screening of mild cognitive impairment (MoCA) and vision

**Time Frame:** This outcome measure will be assessed once during the first measurement (+/- 5-10 minutes).

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Dutch-speaking individuals aged between 45-80 years old
* individuals with normal vision (with glasses or lenses if needed)
* individuals with age-related hearing loss
* individuals with bilateral hearing aids (Phonak Audéo Paradise/Lumity 70)
* individuals who are capable to give consent to participate in the study themselves

Exclusion Criteria:

* user of cochlear implants
* use of influencing medication (for example: Rilatin and antidepressants)
* learning disabilities (for example: dyslexia and dyscalculia)
* (history of) neurological problems (brain tumor, epilepsy, history of stroke, ...)

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** louise.vangoylen@ugent.be

**Name:** Louise Van Goylen, PhD

**Phone:** +32484927235

**Role:** CONTACT

**Contact 2:**

**Email:** hannah.keppler@ugent.be

**Name:** Hannah Keppler, Assoc. Prof.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ghent

**Contacts:**

***Contact 1:***

- **Email:** hannah.keppler@ugent.be

- **Name:** Hannah Keppler, Assoc. Prof.

- **Role:** CONTACT

**Country:** Belgium

**Facility:** University Ghent

**State:** East-Flanders

**Status:** RECRUITING

**Zip:** 9000

#### Overall Officials

**Official 1:**

**Affiliation:** University Ghent

**Name:** Hannah Keppler, Assoc. Prof.

**Role:** PRINCIPAL_INVESTIGATOR

## 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: Hearing Loss, Sensorineural

- 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
