Hearing Loss
Conditions
Brief summary
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.
Interventions
DEVICEHearing aids with noise management features for listening in noise
Device for hearing loss compensation with digital noise management features
DEVICEHearing aid for listening in quiet environments
Device for hearing loss compensation for listening in quiet environments
Sponsors
Toronto Metropolitan University
Sonova AG
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
A single cohort of participants will receive and be assessed in all treatment/intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults (18-99) years * Binaural, symmetrical, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss * Fluent in English
Exclusion criteria
* Minors (17 years or less) * Not able to tolerate wearing of hearing aids * Vulnerable populations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS) | Session 1, 2, 3 and 4; assessed for up to 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Listening Accuracy | Session 1, 2, 3 and 4; assessed for up to 2 hours | Speech understanding in noise percent correct scores |
| Subjective Listening Effort Rating | Session 1, 2, 3 and 4; assessed for up to 2 hours | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Hearing Loss | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 18 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| Age, Continuous | 69 years STANDARD_DEVIATION 7.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 26 Participants | — |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
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.
Time frame: Session 1, 2, 3 and 4; assessed for up to 2 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS) | Hearing aid with noise management | -14.85 Oxygenation (uMol) | Standard Error 4.65 |
| Participants With Hearing Loss | Oxygenation Using Functional Near Infrared Spectroscopy (fNIRS) | Hearing aids for quiet listening | 4.15 Oxygenation (uMol) | Standard Error 4.65 |
Secondary
Listening Accuracy
Speech understanding in noise percent correct scores
Time frame: Session 1, 2, 3 and 4; assessed for up to 2 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Listening Accuracy | Hearing aids with noise management | 75.8 Percentage of words repeated correctly | Standard Deviation 15.2 |
| Participants With Hearing Loss | Listening Accuracy | Hearing aids for quiet listening | 62.3 Percentage of words repeated correctly | Standard Deviation 19.4 |
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.
Time frame: Session 1, 2, 3 and 4; assessed for up to 2 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Subjective Listening Effort Rating | Hearing aids with noise management | 3.08 units on a scale | Standard Deviation 0.96 |
| Participants With Hearing Loss | Subjective Listening Effort Rating | Hearing aids for quiet listening | 4.08 units on a scale | Standard Deviation 0.892 |