Clinical trial NCT05693610: Open-source Hearing Aid Platform Comparisons
Official title: Comparing Outcomes With the Cloud-based and Portable Versions of an Open-source Hearing Aid.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
Hearing Loss, Sensorineural
Keywords: Hearing aid
Hearing loss
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Nadi LLC
First posted: 2023-01-23
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Within-subjects design; Different levels of intervention outcomes are compared
Primary purpose: TREATMENT

Brief summary: New discoveries for hearing loss intervention are often impeded by the proprietary nature of commercial hearing aids and their use in scientific research as "black boxes". An open-source speech platform (OSP) was developed to bridge the gap between audiology research and commercial hearing aid features, to promote innovative solutions to meet the needs of the hearing loss community. The OSP can replicate functions found in commercial hearing aids, and provides tools to researchers to access those functions. The purpose of this study is to evaluate portable and cloud-based platforms of the OSP that will enable a wide range of lab and field applications. All human subjects-related activities will be conducted at Northwestern University (single-site study).

Detailed description: New discoveries for hearing loss intervention are often impeded by the proprietary nature of commercial hearing aids and their use in scientific research as "black boxes". An open-source hearing aid (open-source speech platform or OSP) was developed to bridge the gap between audiology research and the commercialization of hearing aid technologies and to promote innovative solutions to meet the needs of the hearing loss community. The OSP can replicate functions found in commercial hearing aids, and provides tools to researchers and listeners to access those functions. The purpose of this study is to evaluate portable and cloud-based platforms of the OSP that will enable a wide range of lab and field applications by measuring speech perception abilities with the open-source hearing aid in quiet and in noise for adults with and without hearing loss.

The study is a within-subjects design that allows for the comparison of outcomes within the same participant. The study will compare performance with two platforms of the open-source hearing aid (portable and cloud-based) for adults with hearing loss and normal hearing. The study will measure performance using tests of word identification. We will test aided performance with clinically validated hearing aid settings in quiet and in noise. Each participant will be presented with all the test conditions, and the order of presentation of the test conditions will be randomized across participants. Statistical analyses will use a repeated measures model to control for correlation between outcomes for the same participant.

Eligibility criteria: Inclusion Criteria:

* \>= 18 years of age; any sex
* Sensorineural hearing loss with pure-tone thresholds between 25-85 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz
* Speak English as their primary language
* Normal or corrected-to-normal vision
* Participants will be in good health (self-report)

Exclusion Criteria:

* Clinically significant unstable or progressive medical conditions
* Participants who score \< 23 on the cognitive screening test (Montreal Cognitive Assessment)
* Evidence of conductive hearing loss or middle ear issues
* Significant history of otologic or neurologic disorders
* Non English-speaking or non-native English speaking

Primary outcomes:
measure: Word-identification Ability
timeFrame: Post-intervention (1 day)
Secondary outcomes:
measure: Phoneme Confusions
timeFrame: Post-intervention (1 day)
measure: Response Time
timeFrame: Post-intervention (1 day)
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Varsha H Rallapalli, AuD, PhD
role: PRINCIPAL_INVESTIGATOR
References: