Apple Hearing Study

Hearing Loss Clinical Trial

Official title:

Apple Hearing Study Characterization of Headphone Audio Levels, and Optional Wristwatch-Based Environmental Sound Levels, With Variable User Interface

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04172766
• Other study ID #: Pro00037864
• Secondary ID: HUM00167885
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2019
• Est. completion date: November 2024

Study information

• Verified date: February 2022
• Source: Apple Inc.
• Contact: Research Studies Support Center
• Phone: 833-237-3881
• Email: applehearingstudy[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Apple Hearing Study is a partnership between the University of Michigan and Apple to study sound exposure and its impact on hearing health. This groundbreaking study will advance the understanding of how hearing could be impacted over time by exposure to sound at certain levels. The investigators will measure headphone and environmental sound exposures over time among participants, and determine how these exposures impact hearing and stress levels. US residents who own an iPhone, download the Apple Research app and consent to participate will be randomly assigned to two groups, one with a "Basic" user interface in the Research app, and one with an "Advanced" user interface. Users in the "Advanced" group will receive additional information about their exposures and be given additional surveys and hearing tests based on their music and environmental sound exposures. The study will provide investigators with a better understanding of listening behavior and its overall impact on hearing health. This information will in turn help guide public health policy and prevention programs designed to protect and promote hearing health in the US and globally.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150000
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Possession of the following, ascertained from automatic hardware/software/device pairing check:

• iPhone with iOS version 13.2 or later used to complete screening eligibility.

• Optional: Apple Watch (any model) paired with iPhone; an Apple Watch Series 4 or later is required to share environmental sound levels.

• Age = 18 years at time of eligibility screening, ascertained from self-reported date of birth. Potential subjects in the states of Alabama and Nebraska must be 19 or older (legal age of consent in these states), and 21 and older for any subjects in Puerto Rico.

• Live in the United States of America at time of eligibility screening, ascertained from self-report.

• Proficient in written and spoken English, defined by self-report.

Exclusion Criteria:

• No additional exclusion criteria

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Noise-Induced

Intervention

Behavioral:
• Advanced
"Advanced" group users will receive prompts when an acutely high headphone audio level exposure (LEQ equivalent to >97 dBA for >30 minutes) occurs. Those in the WatchOS arm will be prompted when their weekly environmental sound level (7-day LEQ equivalent to >80 dBA for >40 hrs) is high. Either prompt will occur via notification, and will request that the participant review exposure data in the Research app and answer questions related to their exposure. The survey will ask for confirmation that they reviewed the exposure data and perceive it as accuracy, whether or not they used any hearing protection (e.g., ear plugs worn at a rock concert), and any intended listening behavior change resulting from their data review. To minimize notification burden for participants, exposure notification events will occur no more than twice per month. At this same frequency, they will be asked to take an abbreviated audiogram to test for temporary threshold shifts in their hearing level.

Locations

Country	Name	City	State
United States	University of Michigan School of Public Health	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Apple Inc.	World Health Organization

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Wristwatch-based environmental sound levels patterns	Difference in wristwatch-based environmental sound level patterns for participants with "Basic" and "Advanced" user interface on their primary mobile device. Environmental sound level exposures (LEQ, in dBA) will be collected daily. Compared between groups using bivariate and multi-variate methods.	daily up to 730 days
Other	Headphone audio level patterns compared to environmental sound level patterns	Association between headphone audio level patterns and wristwatch-based environmental sound level patterns. Environmental sound level and headphone audio level collected (expressed as LEQ in dBA) among those who opt into the wristwatch portion. Bivariate and multivariate associations will be tested.	daily, for up to 730 days
Other	Association between participants changes in hearing level thresholds related to baseline defined from mobile-app based hearing test results and their environmental sound level patterns	Association between changes relative to baseline in serial mobile-app based hearing tests (Pure Tone Audiometric test and Speech In Noise test) results and wristwatch-based environmental sound level patterns among those who opt into the wristwatch portion of the study	through study completion, up to 2 years
Other	Acute change in hearing status after environmental sound exposure	Evaluation of potential temporary threshold shift (TTS) by prompted abbreviated Pure Tone Audiometry test in the "Advanced" user interface group completed after loud headphone audio level exposure (LEQ equivalent to >97dBA for >30 minutes)	0-24 hours after acute headphone exposure, up to twice monthly for up to 2 years
Other	Association between heart rate patterns and headphone audio level	Heart rate patterns collected during exercise from those that opt into the wristwatch (using the Health app to record heart rate in beats per minute) portion of the study will be correlated with headphone audio levels. This will only be monitored during participants' self-identified exercise sessions. Heart rates (beats per minute) will be related to headphone audio level exposure during the same period.	daily when exercising, for up to 2 years
Other	Association between heart rate patterns and environmental sound level	Heart rate patterns collected during exercise from those that opt into the wristwatch (using the Health app to record heart rate in beats per minute) portion of the study will be correlated with environmental sound level. This will only be monitored during participants' self-identified exercise sessions. Heart rates (beats per minute) will be related to environmental sound level exposure during the same period.	daily when exercising, for up to 2 years
Primary	Change in headphone audio levels patterns over time	Difference in headphone audio level exposure (expressed as LEQ in dBA) patterns for participants with "Basic" and "Advanced" user interface on their primary mobile device	Daily, up to 730 days, each compared to baseline
Primary	Association between quarterly hearing test results and headphone audio level patterns.	Association between serial mobile-app based hearing tests (Pure Tone Audiometry, with results expressed in decibels of hearing level, or dBHL, and Speech In Noise test, with results expressed as a speech recognition threshold) results and headphone audio level exposure patterns using multi-variate methods. Audiograms will be performed quarterly to assess change over time and related to the daily headphone audio level (expressed as LEQ, in dBA)	Through study completion, up to 730 days
Secondary	Acute change in hearing status after headphone audio exposure	Evaluation of potential temporary threshold shift (TTS) by prompted abbreviated Pure Tone Audiometry test in the "Advanced" user interface group completed 0-24 hours after loud headphone audio level exposure (LEQ equivalent to >97dBA for >30 minutes); TTS determined by comparing abbreviated Pure Tone Audiometry results to baseline Pure Tone Audiometry results.	0-24 hours after acute headphone exposure, up to twice monthly for up to 2 years

External Links

•   UM Study Website