Clinical trial NCT04231396: Audiobooks for Hearing Loss App as Auditory Training
Official title: Effects of Audiobooks for Hearing Loss App as Auditory Training for Those With CI and HA Users.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Hearing Impaired Children
Hearing Impairment
Lead sponsor: BioSpeech
Sponsor class: INDUSTRY
Collaborators: name: Oregon Health and Science University
First posted: 2020-01-18
Enrollment: 27
Sex: ALL
Minimum age (years): 9
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 40 subjects will participate in total, including children and adults with HL aided with either Hearing Aids or Cochlear Implants
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of the proposed project is to create an Audiobooks for Hearing Loss (HL) App - an audiobook App that has a wide array of user-selectable features designed to provide auditory training. The effects of the Audiobooks for Hearing Loss App as Auditory Training for those With CI and HA Users was measured with a 6-week trial of using the app and measuring changes in listener abilities and adherence to the program.

Detailed description: Twenty percent or more Americans have a Hearing Loss (HL), a commonly used term that includes congenital deafness as well as aging-related hearing challenges, so severe that it may make communication difficult. Worldwide, this translates into 65 million people with English as a first language.

Hearing aids (HAs) and cochlear implants (CI's) are not enough to remedy this. The types of enhancement these devices can perform is inherently limited due to the requirement that they need to perform their task in real time, since otherwise they would not be lip-synchronized, which is essential in face-to-face communication. For example, they cannot change the temporal structure of incoming speech, even if that may help intelligibility. But there is a deeper shortcoming. When individuals wait too long with obtaining these devices, synaptic and pathway re-organization takes place in the auditory cortex that needs to be addressed, and mere device usage may not be up to this task. Cochlear implants provide a special challenge: Individuals may initially have great difficulty deciphering the unfamiliar sensory input generated by these devices.

There is a growing consensus that HL cannot be addressed with HAs or CIs alone: auditory training is also needed. While face-to-face auditory training is available, this intervention is generally not covered by insurance plans. Auditory training Apps have become available to fill this need in a cost-effective manner. Unfortunately, evidence for the efficacy of these products is weak; a recent large-scale randomized controlled trial found no effect on a wide range of outcome measures. A likely suspect for these results is that most aural rehab Apps are repetitive, even with gamification and rewards. A popular method used by individuals with HL to improve their listening skills is listening to audiobooks. Audiobooks have the strong advantage over many aural rehab Apps of being intrinsically motivating. However, existing audiobooks do not adequately accommodate individuals with more severe levels of HL unless they are fundamentally re-thought.

The goal of the proposed project is to create an Audiobooks for Hearing Loss (HL) App - an audiobook App that has a wide array of user-selectable features designed to provide auditory training: Help individuals with recent Cochlear Implants/Hearing Aids through the difficult initial adjustment process, and help with transitioning at one's own pace toward the goal of understanding "habitual speech" (speech spoken without special effort to be intelligible). Even if not used for auditory training, this app would provide access to audiobooks where standard audiobooks fail. Thus, the App serves both auditory training and accessibility. Proposed features include enhanced ("clear") speech modes, visual support by simultaneous display of text and a talking face, and other features that can be enabled or disabled to serve the user's unique needs.

Eligibility criteria: Inclusion Criteria:

\*Because of the COVID-19 Pandemic and low enrollment numbers for certain HL subgroups in the study, the effectiveness of the Audiobooks for Hearing Loss App was measured for the overall group.

Participants had to fall into one of the following five HL subgroups: (1) Adults with HA, moderate HL (41-55 dB); (2) Adults with HA, moderately-severe to severe HL (56 to 90 dB); (3) Adults with non-recent CI, post-lingually deaf; (4) Children, ages 9+, non-recent CI, pre-lingually deaf; and (5) Adults and Children, ages 9+, recent CI, post-lingually deaf. These five subgroups span broad ranges in terms of: (1) age (adults vs. children); (2) severity of hearing loss; (3) device used (HAs vs. Cis); (4) familiarity with device (recent vs. longer-term); and (5) onset of HL (pre-lingual vs. post-lingual. The team expects the highest efficacy for children and adults with recent CI who are post-lingually deaf; the lowest efficacy for adults with HA with either moderate of severe HL; and intermediate efficacy for children with non-recent CI who are pre-lingually deaf.

* speaking English as first language,
* and being able to read at least a first-grade level.

Exclusion Criteria:

* no suspicions of cognitive deficits or vision impairments that would interfere with system usage or invalidate usability assessment,
* no signs of external ear disease,
* and all participants will be tested with the Expressive One-Word Picture Vocabulary Test, 4th Edition (EOWPVT-4; Brownell 2000), normed for ages of 2 and older, and are required to score in the 15th percentile or better.

Primary outcomes:
measure: Audiobooks Efficacy: Change in Slope of Curve for SNR Loss Scores on a Scale/Week for Partial BKB-SIN Hearing Test
timeFrame: 6 weeks
Secondary outcomes:
measure: Audiobooks Positive Responses: Percentage of Positive Responses to Final Usability Survey Question: Would You Buy or Recommend Audiobooks for HL App as Auditory Training
timeFrame: 6 weeks
measure: Audiobooks Adherence: Overall Mean Score of Weekly Goals Met for HA and CI Users Using the Audiobooks for HL App as an Auditory Training Program
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
References: