Hearing LossNCT05330585
fNIRs, Listening Effort, and Speech Intelligibility
A study testing Hearing aids and Unaided in people with Hearing Loss, run by Sonova AG at 1 site in Canada.
Trial 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. Adults with hearing loss will be asked to repeat the final word from low-context sentences in noise at two SNRs; a hard SNR (individually-measured SNR-50), and an easy SNR (SNR-50 + 10 dB)… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing aids and Unaided
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 3 May 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18-99 years) with ≥3 months hearing aid experience
- binaural, symmetric, sensorineural N2 (mild) to N6 (severe) hearing loss
- fluent in English
Who cannot join
- children/teenagers
- normal hearing or hearing loss exceeding N6 (severe) by 10 dB
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Near-infrared Spectroscopy (fNIRS) as a Measure of Listening Effort and Speech Intelligibility in Adults With Hearing Loss
The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Adults with hearing loss will be asked to repeat the final word from low-context sentences in noise at two SNRs; a hard SNR (individually-measured SNR-50), and an easy SNR (SNR-50 + 10 dB) both without and with hearing aids set to a directional mode. The procedure will be a within-subject repeated measures. Stimuli will be randomized.
Read the detailed description
See above.
- Conditions
- Hearing Loss
- Being tested
- Hearing aids, Unaided
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aidsDevice
Also called Investigational
Participants will listen to stimuli in the environment while wearing hearing aids which should make the stimuli more audible. Speech in noise performance is expected to improve and PFC oxygenation is expected to be reduced in this condition.
UnaidedOther
Also called Control
Participants will listen to stimuli in the environment with their hearing loss. Speech in noise performance is expected to decline and PFC oxygenation is expected to be increased in this condition.
| Study group | Role | What they receive |
|---|---|---|
| Participants with hearing loss. | Experimental | Participants with hearing loss. Receives: Device: Hearing aids; Other: Unaided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Listening effort
Listening effort inferred from infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. A higher concentration is indicative of more listening effort.
Measured: Up to 2 hours during 1 session
Speech-in-noise performance
Number of words repeatedly correctly for a given listening condition.
Measured: Up to 2 hours during 1 session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start3 May 2022
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Toronto Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Jinyu Qian, PhD, Principal investigator, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330585
- Sponsor's protocol ID
- SRF-1412
- Status last verified
- Mar 2022
- First submitted
- 8 Apr 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Near-infrared Spectroscopy (fNIRS) as a Measure of Listening Effort and Speech Intelligibility in Adults With Hearing Loss
- ClinicalTrials.gov ID
- NCT05330585
- Acronym / sponsor ID
- SRF-1412
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- Toronto Metropolitan University
- Study start
- 3 May 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Adults with hearing loss will be asked to repeat the final word from low-context sentences in noise at two SNRs; a hard SNR (individually-measured SNR-50), and an easy SNR (SNR-50 + 10 dB) both without and with hearing aids set to a directional mode. The procedure will be a within-subject repeated measures. Stimuli will be randomized.
Detailed description
See above.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with hearing loss. | Experimental | Device: Hearing aids, Other: UnaidedParticipants with hearing loss. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (18-99 years) with ≥3 months hearing aid experience
- binaural, symmetric, sensorineural N2 (mild) to N6 (severe) hearing loss
- fluent in English
Key exclusion criteria (2 listed)
- children/teenagers
- normal hearing or hearing loss exceeding N6 (severe) by 10 dB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing aidsAlso: InvestigationalParticipants will listen to stimuli in the environment while wearing hearing aids which should make the stimuli more audible. Speech in noise performance is expected to improve and PFC oxygenation is expected to be reduced in this condition. | Device | Participants with hearing loss. |
| UnaidedAlso: ControlParticipants will listen to stimuli in the environment with their hearing loss. Speech in noise performance is expected to decline and PFC oxygenation is expected to be increased in this condition. | Other | Participants with hearing loss. |
Primary outcome
Listening effort
Time frame: Up to 2 hours during 1 session
Listening effort inferred from infrared light scattered from the prefrontal cortex, which is indicative of concentration of oxygenated blood in that region. A higher concentration is indicative of more listening effort.
Speech-in-noise performance
Time frame: Up to 2 hours during 1 session
Number of words repeatedly correctly for a given listening condition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinyu Qian, PhD principal investigator
Sonova AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aids and Unaided in people with Hearing Loss, run by Sonova AG at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Listening effort (time frame: Up to 2 hours during 1 session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022; AzTrials last refreshed its copy on 1 Nov 2026.