Hearing LossNCT04231396
Audiobooks for Hearing Loss App as Auditory Training
A study testing Audiobooks for hearing loss App in people with Hearing Loss and Hearing Impaired Children, run by BioSpeech at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Hearing Impaired Children, Hearing Impairment
- What is being tested?
- Audiobooks for hearing loss App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2021to 14 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 9 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Audiobooks for Hearing Loss App as Auditory Training for Those With CI and HA Users.
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.
Read the 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.
- Conditions
- Hearing Loss, Hearing Impaired Children, Hearing Impairment
- Being tested
- Audiobooks for hearing loss App
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiobooks for hearing loss AppOther
Same as Arm 1
| Study group | Role | What they receive |
|---|---|---|
| HA and CI Users using Audiobooks for Hearing Loss for Auditory Training | Other | study participants will be seen weekly for 12 weeks and will use the Audiobooks for HL App for the final 6 weeks using the App at least two hours per week on their own. The researcher will conduct 12 weekly in-home visits where the following will be done:
First 6 weeks:
• Partial BKB-SIN will be administered
Final 6 weeks:
* Partial BKB-SIN will be administered
* Conduct a comprehension test.
* Address any usability issues the participant brings up.
* Review and set new weekly goals Final session: Conduct Final Usability survey Receives: Other: Audiobooks for hearing loss App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiobooks Efficacy: Change in Slope of Curve for SNR Loss Scores on a Scale/Week for Partial BKB-SIN Hearing Test
Speech in noise test; partial BKB-SIN hearing test. SNR Loss scores based on normative sample data on decibel (dB) measures. where Minimum value is 0 dB, Maximum value 15+ dB. Lower scores mean better outcome, 0-3dB = hearing normal; 3-7 dB = Mild SNR loss; 7-15 dB = Moderate SNR loss; >15 db = Severe SNR loss. Slopes of BKB-SIN (Background Noise partial tests) were measured from the Auditory Training portion of the study: weeks 7-12. We used a smoothing method for statistical analysis: isotonic regression (isoreg(), via R). This method is the fundamental assumption that the scores of these 6 weeks will be non-increasing indicating better outcome; improved listening scores on the BKB-SIN partial tests.
Measured: 6 weeks
Secondary outcomes (2)
Audiobooks Positive Responses: Percentage of Positive Responses to Final Usability Survey Question: Would You Buy or Recommend Audiobooks for HL App as Auditory Training
Percentage of positive answers on Final Usability Survey: "Would you buy or recommend the Audiobooks for Hearing Loss App for yourself or someone you know who recently got a new Hearing Aid or Cochlear Implant." Clients filled out final usability survey at end of 12-week study.
Measured: 6 weeks
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
Meeting specific weekly goals (yes/no) for using the Audiobooks for HL App with was a measure of adherence to this Auditory Training program. Researcher tracked whether HA and CI Users met their weekly goals during weekly check-ins. The researcher recorded information from the App's dashboard about whether the client had met the previous week's goals. The dashboard shows the Client's weekly goals of: Minutes of listening, minutes of listening in Standard Speech, minutes of Pure Listening (audio only), minutes of no text support, minutes of listening in background noise. New goals were updated for the upcoming week with increased difficulty based on goal performance.
The scale used for the overall mean scores reported is 0 to 1.0 where the minimum value is 0 and maximum value is 1. Computing in percentage 0 = 0% for meeting that specific goal and 1.0 = 100% for meeting that specific goal, so higher scores closer to 1.0 mean greater adherence to this Auditory Training program.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start25 Feb 2021
- Primary completion14 Sep 2021
- Study completion14 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 40 subjects will participate in total, including children and adults with HL aided with either Hearing Aids or Cochlear Implants
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioSpeech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Kirsty Lindaas-Hamilton, BioSpeech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231396
- Sponsor's protocol ID
- 1R44DC017403-01A1
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2020
- Last updated
- 14 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Audiobooks for Hearing Loss App as Auditory Training for Those With CI and HA Users.
- ClinicalTrials.gov ID
- NCT04231396
- Acronym / sponsor ID
- 1R44DC017403-01A1
- Conditions
- Hearing Loss, Hearing Impaired Children, Hearing Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- BioSpeechIndustry (pharma, biotech, devices)
- Collaborators
- Oregon Health and Science University
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 14 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 40 subjects will participate in total, including children and adults with HL aided with either Hearing Aids or Cochlear Implants
| Arm | Type | Receives |
|---|---|---|
| HA and CI Users using Audiobooks for Hearing Loss for Auditory Training | Other | Other: Audiobooks for hearing loss Appstudy participants will be seen weekly for 12 weeks and will use the Audiobooks for HL App for the final 6 weeks using the App at least two hours per week on their own. The researcher will conduct 12 weekly in-home visits where the following will be done: First 6 weeks: • Partial BKB-SIN will be administered Final 6 weeks: * Partial BKB-SIN will be administered * Conduct a comprehension test. * Address any usability issues the participant brings up. * Review and set new weekly goals Final session: Conduct Final Usability survey |
Who may qualify
- Ages
- 9 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Audiobooks for hearing loss AppSame as Arm 1 | Other | HA and CI Users using Audiobooks for Hearing Loss for Auditory Training |
Primary outcome
Audiobooks Efficacy: Change in Slope of Curve for SNR Loss Scores on a Scale/Week for Partial BKB-SIN Hearing Test
Time frame: 6 weeks
Speech in noise test; partial BKB-SIN hearing test. SNR Loss scores based on normative sample data on decibel (dB) measures. where Minimum value is 0 dB, Maximum value 15+ dB. Lower scores mean better outcome, 0-3dB = hearing normal; 3-7 dB = Mild SNR loss; 7-15 dB = Moderate SNR loss; >15 db = Severe SNR loss. Slopes of BKB-SIN (Background Noise partial tests) were measured from the Auditory Training portion of the study: weeks 7-12. We used a smoothing method for statistical analysis: isotonic regression (isoreg(), via R). This method is the fundamental assumption that the scores of these 6 weeks will be non-increasing indicating better outcome; improved listening scores on the BKB-SIN partial tests.
2 secondary outcomes
Audiobooks Positive Responses: Percentage of Positive Responses to Final Usability Survey Question: Would You Buy or Recommend Audiobooks for HL App as Auditory Training
Time frame: 6 weeks
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
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiobooks for hearing loss App in people with Hearing Loss and Hearing Impaired Children, run by BioSpeech at 1 site in United States.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 14 Jan 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Audiobooks Efficacy: Change in Slope of Curve for SNR Loss Scores on a Scale/Week for Partial BKB-SIN Hearing Test (time frame: 6 weeks). 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 14 Jan 2022.