Audiobooks for Hearing Loss App as Auditory Training

NCT04231396 | Completed Results

• 1 other identifier: 1R44DC017403-01A1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss; Hearing Impaired Children; Hearing Impairment

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  6 weeks

Study Arms (1)

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

Other: Audiobooks for hearing loss App

Interventions

Audiobooks for hearing loss App OTHER

Same as Arm 1

HA and CI Users using Audiobooks for Hearing Loss for Auditory Training

Eligibility Criteria

• Age: 9 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \*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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioSpeech: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Sound Recordings

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Limitations and Caveats

COVID-19 impacted enrollment causing an imbalance of subgroup numbers for comparisons, so the effectiveness of the Audiobooks was measured for the overall group. The partial BKB-SIN hearing test that was given weekly consisted of 4 lists of sentences vs. the comprehensive BKB-SIN hearing test, which is comprised of 36 lists of sentences. The smaller sample size; number of items used on the partial BKB-SIN hearing test often produced significant variability which can lead to unreliable data.

Results Point of Contact

• Title: K. Lindaas, Principal Investigator
• Organization: BioSpeech

kirstylindaas@biospeech.com

(503) 522-6276

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 40 subjects will participate in total, including children and adults with HL aided with either Hearing Aids or Cochlear Implants

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: February 25, 2021
• Primary Completion: September 14, 2021
• Study Completion: September 14, 2021
• Last Updated: January 14, 2022
• Results First Posted: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)