Apple Hearing Study: Characterization of Headphone Audio Levels, and Optional Wristwatch-Based Environmental Sound Levels, With Variable User Interface
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Apple Inc.
- 入组人数
- 300,000
- 试验地点
- 1
- 主要终点
- Headphone audio level patterns
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Headphone audio level patterns
时间窗: From enrollment to the end of followup at 10 years
For the entire cohort over various timeframes
Difference in Headphone Audio Level patterns
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From enrollment to the end of followup after 10 years
Experience with hearing related tools and device
次要结局
- Difference in Environmental Sound Level Patterns(From enrollment to the end of followup after 10 years)
- Association between Headphone Audio Levels and Environmental Sound Level patterns(From enrollment to the end of followup after 10 years)
- Association between Environmental Sound Level patterns and Pure Tone Audiometry.(From enrollment to the end of followup after 10 years)
- Association between Environmental Sound Level patterns and Speech in Noise(From enrollment to the end of followup after 10 years)
- Association between Environmental Sound Level patterns and tinnitus matching task(From enrollment to the end of followup after 10 years)
- Association between general health and personal characteristics and sound levels and hearing tasks(From enrollment to the end of followup after 10 years)
- Change from baseline in abbreviated Pure Tone Audiometry following loud environmental noise notification(From enrollment to the end of followup after 10 years)
- Assess reported participant experience(From enrollment to the end of followup after 10 years)
- Association between heart rate measures and Headphone Audio Level patterns(From enrollment to the end of followup after 10 years)
- Association between heart rate measures and Environmental Sound Level patterns(From enrollment to the end of followup after 10 years)
研究者
Richard Neitzel
Associate Professor of Environmental Health Sciences and Associate Professor of Global Public Health
University of Michigan