Apple Hearing Study
- Conditions
- Hearing Loss, Noise-InducedHearing LossTinnitus
- Interventions
- Behavioral: Advanced
- Registration Number
- NCT04172766
- Lead Sponsor
- Apple Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300000
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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.
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Live in the United States of America at time of eligibility screening, ascertained from self-report.
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Proficient in written and spoken English, defined by self-report.
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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.
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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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Advanced Advanced Participants in the second ("Advanced") group will have a UI that includes notifications prompting personal data pattern review in the Health app and then prompting to do an abbreviated Pure Tone Audiometry module completed 0-24 hours after loud headphone audio level exposure (equivalent continuous average noise level, or LEQ, to \>97 A-weighted decibels, or dBA for \>30 minutes) to evaluate for a temporary threshold shift from baseline.
- Primary Outcome Measures
Name Time Method Headphone audio level patterns From enrollment to the end of followup at 10 years For the entire cohort over various timeframes
Difference in Headphone Audio Level patterns From enrollment to the end of followup at 10 years This will include assessment of sound pressure level and time at baseline and over the duration of the study.
Association between Headphone Audio Level patterns and Pure Tone Audiometry From enrollment to the end of followup at 10 years Analysis will occur for each tested frequency (dB HL at 125 Hz, 250 Hz, 500 Hz, 1 kHz, 2 kHz, 4kHz, and 8 kHz assessed for both ears) for both ears at baseline and over the duration of the study.
Association between Headphone Audio Level patterns and Speech in Noise From enrollment to the end of followup at 10 years Analysis will assess the speech recognition threshold and it's relationships with HAL at baseline and over the duration of the study
Association between Headphone Audio Level patterns and tinnitus matching From enrollment to the end of followup at 10 years At baseline and over the duration of the study
Association between general health and individual characteristics and sound levels and/or audiometry tasks From enrollment to the end of followup after 10 years Headphone Audio Levels will be assessed as the sound level and the audiometry tasks assessed will be Pure Tone Audiometry, Speech in Noise, and tinnitus matching
Change from baseline to final audiometry From enrollment to the end of followup after 10 years Including both Pure Tone Audiometry and Speech in Noise
Change from baseline in abbreviated Pure Tone Audiometry following high headphone audio level notification From enrollment to the end of followup after 10 years This comparison will occur for two frequencies (1 kHz and 4 kHz for both ears) within 24 hours of acute loud Headphone Audio Level exposure (LEQ equivalent to \>97 dBA for \>30 minutes)
Headphone Audio Level association with baseline survey questions From enrollment to the end of followup after 10 years This will includes questions about typical headphone us, typical environmental exposures, and hearing ability.
Baseline Audiometry association with baseline survey questions From enrollment to the end of followup after 10 years Baseline Audiometry includes both Pure Tone Audiometry and Speech in Noise. Survey questions include those regarding typical headphone use, typical environmental exposures, and hearing ability.
Final Audiometry association with end-of-study survey questions At the end of followup after 10 years Final Audiometry includes Pure Tone Audiometry and Speech in Noise. The end-of-study survey questions include typical headphone use, typical environmental exposures, and hearing ability.
Change in survey questions From enrollment to the end of followup after 10 years Survey questions regarding exposure changes over the course of the study
Association between hearing ability and changes in hearing health and related health conditions From enrollment to the end of followup after 10 years Hearing ability is evaluated both as perceived and evaluated. Changes in hearing health include audiometry and tinnitus. Related health conditions include items such as cognition, sleep, mental health, activity, mobility, and more.
Descriptive assessment of participant use and experience From enrollment to the end of followup after 10 years Experience with hearing related tools and device
- Secondary Outcome Measures
Name Time Method Difference in Environmental Sound Level Patterns From enrollment to the end of followup after 10 years Including sound pressure level and time at baseline and over the duration of the study. This outcome is only among participants that use Apple Watch.
Association between Headphone Audio Levels and Environmental Sound Level patterns From enrollment to the end of followup after 10 years This outcome is only among participants that use Apple Watch.
Association between Environmental Sound Level patterns and Pure Tone Audiometry. From enrollment to the end of followup after 10 years At baseline and over the duration of the study. This outcome is only among Participants that use Apple Watch.
Association between Environmental Sound Level patterns and Speech in Noise From enrollment to the end of followup after 10 years At baseline and over the duration of the study. This outcome is only among Participants that use Apple Watch.
Association between Environmental Sound Level patterns and tinnitus matching task From enrollment to the end of followup after 10 years At baseline and over the duration of the study. This outcome is only among Participants that use Apple Watch.
Association between general health and personal characteristics and sound levels and hearing tasks From enrollment to the end of followup after 10 years Sound levels include Environmental Sound Levels. Hearing tasks includes Pure Tone Audiometry, Speech in Noise, and Tinnitus matching. This outcome is only among Participants that use Apple Watch.
Change from baseline in abbreviated Pure Tone Audiometry following loud environmental noise notification From enrollment to the end of followup after 10 years This assessment will be for two frequencies (1 kHz and 4 kHz for both ears) tested within 24 hours of acute loud Environmental Sound Level exposure (LEQ equivalent to \>97 dBA for \>30 minutes). This outcome is only among Participants that use Apple Watch.
Assess reported participant experience From enrollment to the end of followup after 10 years Experience will be assessed via survey delivered with a notification after a prolonged loud environmental sound level exposure (LEQ equivalent to \>80 dBA for \>40 hours). This outcome is only among Participants that use Apple Watch.
Association between heart rate measures and Headphone Audio Level patterns From enrollment to the end of followup after 10 years This will include heart rate during activity (as assessed by logged Workouts and Active Energy trends by Watch). This outcome is only among participants that use Apple Watch.
Association between heart rate measures and Environmental Sound Level patterns From enrollment to the end of followup after 10 years This includes heart rate during activity (as assessed by logged Workouts and Active Energy trends by Watch). This outcome is only among participants that use Apple Watch.
Trial Locations
- Locations (1)
University of Michigan School of Public Health
🇺🇸Ann Arbor, Michigan, United States