Clinical trial NCT04172766: Apple Hearing Study
Official title: Apple Hearing Study: Characterization of Headphone Audio Levels, and Optional Wristwatch-Based Environmental Sound Levels, with Variable User Interface
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss, Noise-Induced
Hearing Loss
Tinnitus
Keywords: Hearing Loss
Noise Exposure
Noise Induced Hearing Loss
Listening Volume
Environmental Noise
Music
Audiometry
Speech-in-Noise
Hearing Ability
Headphones
Headphone audio level
Ambient noise
Occupational noise
Heart rate
Tinnitus
Lead sponsor: Apple Inc.
Sponsor class: INDUSTRY
Collaborators: name: World Health Organization
First posted: 2019-11-21
Enrollment: 300000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults age 18 or older that live in the U.S. or U.S. territories and have iPhone with the Research app installed.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* Participants must NOT share their iCloud account, iPhone or other devices such as Apple Watch with anyone else as this would make it challenging for researchers to use their information.
* Possession of the following, ascertained from automatic hardware/software/device pairing check:

  * iPhone with iOS versions capable of supporting the Research app 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.

Primary outcomes:
measure: Headphone audio level patterns
timeFrame: From enrollment to the end of followup at 10 years
measure: Difference in Headphone Audio Level patterns
timeFrame: From enrollment to the end of followup at 10 years
measure: Association between Headphone Audio Level patterns and Pure Tone Audiometry
timeFrame: From enrollment to the end of followup at 10 years
measure: Association between Headphone Audio Level patterns and Speech in Noise
timeFrame: From enrollment to the end of followup at 10 years
measure: Association between Headphone Audio Level patterns and tinnitus matching
timeFrame: From enrollment to the end of followup at 10 years
measure: Association between general health and individual characteristics and sound levels and/or audiometry tasks
timeFrame: From enrollment to the end of followup after 10 years
measure: Change from baseline to final audiometry
timeFrame: From enrollment to the end of followup after 10 years
measure: Change from baseline in abbreviated Pure Tone Audiometry following high headphone audio level notification
timeFrame: From enrollment to the end of followup after 10 years
measure: Headphone Audio Level association with baseline survey questions
timeFrame: From enrollment to the end of followup after 10 years
measure: Baseline Audiometry association with baseline survey questions
timeFrame: From enrollment to the end of followup after 10 years
measure: Final Audiometry association with end-of-study survey questions
timeFrame: At the end of followup after 10 years
measure: Change in survey questions
timeFrame: From enrollment to the end of followup after 10 years
measure: Association between hearing ability and changes in hearing health and related health conditions
timeFrame: From enrollment to the end of followup after 10 years
measure: Descriptive assessment of participant use and experience
timeFrame: From enrollment to the end of followup after 10 years
Secondary outcomes:
measure: Difference in Environmental Sound Level Patterns
timeFrame: From enrollment to the end of followup after 10 years
measure: Association between Headphone Audio Levels and Environmental Sound Level patterns
timeFrame: From enrollment to the end of followup after 10 years
measure: Association between Environmental Sound Level patterns and Pure Tone Audiometry.
timeFrame: From enrollment to the end of followup after 10 years
measure: Association between Environmental Sound Level patterns and Speech in Noise
timeFrame: From enrollment to the end of followup after 10 years
measure: Association between Environmental Sound Level patterns and tinnitus matching task
timeFrame: From enrollment to the end of followup after 10 years
measure: Association between general health and personal characteristics and sound levels and hearing tasks
timeFrame: From enrollment to the end of followup after 10 years
measure: Change from baseline in abbreviated Pure Tone Audiometry following loud environmental noise notification
timeFrame: From enrollment to the end of followup after 10 years
measure: Assess reported participant experience
timeFrame: From enrollment to the end of followup after 10 years
measure: Association between heart rate measures and Headphone Audio Level patterns
timeFrame: From enrollment to the end of followup after 10 years
measure: Association between heart rate measures and Environmental Sound Level patterns
timeFrame: From enrollment to the end of followup after 10 years
Other outcomes:
measure: Impact of hearing ability on other related aspects of health
timeFrame: From enrollment to the end of followup after 10 years
measure: Assess novel versions of hearing assessments
timeFrame: From enrollment to the end of followup after 10 years
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Public Health
state: Michigan
Study officials:
affiliation: University of Michigan
name: Richard L Neitzel, PhD, MS, CIH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Lauren M Smith, MS, MPH
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: Joyce M Daniels, MA
role: STUDY_CHAIR
References:
citation: Smith LM, Wang L, Mazur K, Carchia M, DePalma G, Azimi R, Mravca S, and Neitzel RL. Impacts of COVID-19-related social distancing measures on personal environmental sound exposures. Environmental Research Letters. Oct 2020. 15.10: 104094. https://iopscience.iop.org/article/10.1088/1748-9326/abb494
citation: Neitzel RL, Smith L, Wang L, Green G, Block J, Carchia M, Mazur K, DePalma G, Azimi R, Villanueva B. Toward a better understanding of nonoccupational sound exposures and associated health impacts: Methods of the Apple Hearing Study. J Acoust Soc Am. 2022 Mar;151(3):1476. doi: 10.1121/10.0009620.