- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06840015
Use of Airpod Pros as Assistive Technology
The goal of this study is to investigate the suitability and effectiveness of the AirPod Pro 2nd and 3rd generation (AP) as hearing assistive technology for individuals with mild-to-moderate hearing loss when listening in noisy environments. Researchers will compare four types of assistive technology: hearing aids (HAs), AP, dedicated wireless remote microphones, and Smartphone wireless remote microphone.
The main questions it aims to answer are:
- Which assistive technology provides the greatest benefit for speech recognition in noisy environments?
- How do these devices impact listening effort, as measured by reaction time in a dual-task activity and changes in pupil size?
- What are participants' preferences for each device based on how easy it is to understand speech and their overall satisfaction? Participants will visit the lab for a single 3-hour session. They will listen to sentences using each device and repeat what they hear. During this task, their reaction times for the secondary task and changes in pupil size will be measured.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A total of 24 participants will be recruited from the Callier Center, local audiology offices, support groups, and senior centers and will first undergo a pure-tone hearing test in a sound booth. The preferred ear tip for the Airpod Pro 3rd generation (AP) will be selected based on participant's comfort, ensuring it passes the ear tip fit test in the iPhone operating system. Similarly, the appropriate ear tip for the receiver-in-the canal Phonak Paradise hearing aid will be selected. The devices will be fit bilaterally and programmed for the individual's hearing loss using the smartphone or computer. Real-ear measurements will be then conducted with both the HAs and the APs to verify that their amplification reaches the The National Acoustic Laboratories non-linear version 2 (NAL-NL2) target level bilaterally (± 5 decibels) for the individual's degree of hearing loss, using Audioscan Verifit 2 (version 4.26.3).
The speech recognition threshold (SRT) at 70.7% will first be measured using the AP and a 2-down-1-up adaptive procedure, adjusting the signal-to-noise ratio (SNR) of babble noise using Hearing in Noise Test (HINT). The sentence will be presented at 65 dBA constant level from Knowles Electronics Manikin for Acoustic Research (KEMAR) with a mouth simulator positioned 1 meter at 0 degrees azimuth. The noise will be presented from the two speakers positioned 1 meter at 90- and 270-degrees azimuth. The participant must repeat the key words correctly. The SNR step size will initially be set to 4 dB for the first three reversals to enable rapid convergence, then reduced to 2 dB to refine the threshold measurement. This procedure will continue until six to eight reversals are obtained to ensure threshold stability. This approach will provide a reliable measurement of the SRT with the AP and allow enough range for improvements to comparison with other assistive technologies.
Next, the participants will complete a dual-task paradigm at the SNR that resulted in 70.7% performance with AP, both without assistive technology and with technology including HA, AP, dedicated wireless remote microphones (DRM), or Smartphone wireless remote microphone (SRM). The target speech will be presented through KEMAR with a mouth simulator positioned 1 meter at 0 degrees azimuth, with babble noise from two speakers positioned 1 meter at 90- and 270-degrees azimuth. The primary task will involve sentence recognition in babble noise using different AzBio sentence lists mentioned above. The secondary task will utilize a working memory task from PALETA (www.paleta.fob.usp.br). While listening to and repeating the AzBio sentence aloud, participants will simultaneously look at the screen, memorize, and click the sequence of colors. Listening effort will be measured by calculating the difference in response time (RT) for the secondary task between the dual-task condition (primary and secondary) and single-task (secondary only) condition.
Following this, the pupil diameter will be measured while participants repeat sentences presented, serving as an additional measure to more reliably assess listening effort under consistent same speaker, SRT and device settings. The AzBio sentence list (Spahr et al., 2012), consisting of 20 sentences, will be used with each assistive technology condition, totaling five sets. Pupil diameter will be captured using the Tobii Pro Lab Analyzer software (version 1.217, Tobii Technology AB, Stockholm, Sweden) positioned 1 meter in front of the participant. This measure will provide two key insights: listening effort and speech recognition ability. We will then compare listening effort and speech recognition with and without each assistive device to determine which assistive technology provides the greatest benefit for speech recognition and listening effort in noisy environments.
Finally, participants will complete a questionnaire to evaluate their experience with each assistive technology. During the pupillometry session, they will rate the difficulty of the sentence recognition task immediately after using each device. At the end of the session, participants will select their preferred assistive technology with the reason for their choice.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Linda Thibodeau, Ph.D.
- Phone Number: 972-883-3108
- Email: thib@utdallas.edu
Study Contact Backup
- Name: Seeon Kim, Ph.D.
- Phone Number: 4806164403
- Email: Seeon.Kim@utdallas.edu
Study Locations
-
-
Texas
-
Richardson, Texas, United States, 75080
- Recruiting
- Callier Center for Communication Disorders
-
Contact:
- Kim, Ph.D.
- Phone Number: 480-616-4403
- Email: Seeon.Kim@utdallas.edu
-
Principal Investigator:
- Linda Thibodeau, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 to 60 years.
- Fluent English speakers.
- Mild-to-moderate hearing loss confirmed by a pure-tone hearing test (average hearing threshold screening 25 to 55 dB HL across octave frequencies from 250 to 8000 Hz).
- Individuals with no prior hearing aid experience for a year.
Exclusion Criteria:
- Normal hearing.
- Hearing loss worse than moderate.
- Neurological, psychiatric, or ophthalmological conditions that might alter the pupil response.
- Non-fluent English speakers.
- Individuals with prior hearing aid experience more than a year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment group
AP, HA, ... (Randomized)
|
All participants will use and evaluate four types of assistive technology: hearing aids, Airpod pro 2nd and 3rd generation, dedicated wireless remote microphones, and Smartphone wireless remote microphone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reponse time of secondary working memory task
Time Frame: The measurement will be conducted immediately following the intervention within the 2-hour single session.
|
It refers to the amount of time it takes for a participant to react to and complete the secondary working memory task, performed alongside the primary task (speech recognition).
This measurement reflects the participant's cognitive processing speed and listening effort.
It is measured in seconds (s).
Faster values indicate better performance.
|
The measurement will be conducted immediately following the intervention within the 2-hour single session.
|
|
Pupil diameter
Time Frame: The measurement will be conducted immediately following the intervention within the 2-hour single session.
|
Pupil diameter reflects the motivation to exert effort through physiological mechanisms that maintain homeostasis, making it a reliable indicator of listening effort.
It is measured in millimeters (mm).
Larger pupil diameters typically indicates greater exerted effort.
|
The measurement will be conducted immediately following the intervention within the 2-hour single session.
|
|
Questionnaire
Time Frame: The measurement will be conducted immediately following the intervention within the 2-hour single session.
|
Participants are asked to rate how easy it was to understand the speaker with each device.
This scale ranges from "Very easy", "Easy", "Ok", "Hard", to "Very hard".
They are also asked to select their most preferred device.
|
The measurement will be conducted immediately following the intervention within the 2-hour single session.
|
|
Speech recognition threshold at 70.7%
Time Frame: The measurement will be conducted immediately following the intervention within the 2-hour single session.
|
Speech recognition threshold (SRT) at 70.7% is the noise level at which a person can correctly repeat 70.7% of sentences.
Determine the appropriate dB SNR to measure sentence recognition with assistive technologies.
It is measured in decibels (dB).
Lower values indicate better performance.
|
The measurement will be conducted immediately following the intervention within the 2-hour single session.
|
Collaborators and Investigators
Investigators
- Study Director: Linda Thibodeau, Ph.D., The University of Texas at Dallas
- Principal Investigator: Seeon Kim, Ph.D., Callier Center for Communication Disorders
Publications and helpful links
General Publications
- Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.
- Nilsson M, Soli SD, Sullivan JA. Development of the Hearing in Noise Test for the measurement of speech reception thresholds in quiet and in noise. J Acoust Soc Am. 1994 Feb;95(2):1085-99. doi: 10.1121/1.408469.
- Levitt H. Transformed up-down methods in psychoacoustics. J Acoust Soc Am. 1971 Feb;49(2):Suppl 2:467+. No abstract available.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-25-148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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