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| Name | Class |
|---|---|
| Toronto Metropolitan University | OTHER |
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The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Participants will be instructed to listen to sentences in noise at a challenging signal-to-noise-ratio, and to repeat the word that they heard and rate how much subjective listening effort was required in order to make out the words. fNIRS will be measured throughout. Participants will complete the task using a hearing aid program intended for listening in quiet, and a hearing aid program with new advanced noise management features.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital noise management, then quiet listening | Experimental | Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation with digital noise management features, followed by the device for hearing loss compensation for listening in quiet environments. |
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| Quiet listening, then digital noise management | Experimental | Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation for listening in quiet environments, followed by the device for hearing loss compensation with digital noise management features. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing aids with noise management features for listening in noise | Device | Device for hearing loss compensation with digital noise management features |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS) | Infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. fNIRS in the prefrontal cortex is intended to index both motivation and listening effort. | Session 1, 2, 3 and 4; assessed for up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Listening Accuracy | Speech understanding in noise percent correct scores | Session 1, 2, 3 and 4; assessed for up to 2 hours |
| Subjective Listening Effort Rating | Participants rate how much listening effort was required in order to make out a sentence from 1-7, where lower scores mean less effort required. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinyu Qian, PhD | Sonova AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonova Innovation Centre Toronto | Mississauga | Ontario | L5L1J3 | Canada |
There is no plan to share individual participant data with other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Digital Noise Management, Then Quiet Listening | Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation with digital noise management features, followed by the device for hearing loss compensation for listening in quiet environments. |
| FG001 | Quiet Listening, Then Digital Noise Management | Participants with hearing loss who are candidates for hearing aids first listen using the device for hearing loss compensation for listening in quiet environments, followed by the device for hearing loss compensation with digital noise management features. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hearing Loss | All participants will have hearing loss and be assigned to all two interventions. The interventions consist of calm-situation listening and noise management feature. Hearing aids with noise management features for listening in noise: Device for hearing loss compensation with digital noise management features Hearing aid for listening in quiet environments: Device for hearing loss compensation for listening in quiet environments |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS) | Infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. fNIRS in the prefrontal cortex is intended to index both motivation and listening effort. | Posted | Mean | Standard Error | Oxygenation (uMol) | Session 1, 2, 3 and 4; assessed for up to 2 hours |
|
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Session 1, 2, 3 and 4; assessed for up to 2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hearing Loss | All participants will have hearing loss and be assigned to all two interventions. The interventions consist of calm-situation listening and noise management feature. Hearing aids with noise management features for listening in noise: Device for hearing loss compensation with digital noise management features Hearing aid for listening in quiet environments: Device for hearing loss compensation for listening in quiet environments |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Vaisberg | Sonova | 9057456785 | jonathan.vaisberg@sonova.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2025 | May 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| D001314 | Auscultation |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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A single cohort of participants will receive and be assessed in all treatment/intervention
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| Hearing aid for listening in quiet environments | Device | Device for hearing loss compensation for listening in quiet environments |
|
| Session 1, 2, 3 and 4; assessed for up to 2 hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
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| Secondary | Listening Accuracy | Speech understanding in noise percent correct scores | Posted | Mean | Standard Deviation | Percentage of words repeated correctly | Session 1, 2, 3 and 4; assessed for up to 2 hours |
|
|
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| Secondary | Subjective Listening Effort Rating | Participants rate how much listening effort was required in order to make out a sentence from 1-7, where lower scores mean less effort required. | Posted | Mean | Standard Deviation | units on a scale | Session 1, 2, 3 and 4; assessed for up to 2 hours |
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| 0 |
| 26 |
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| 0 |
| 26 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |