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Apple Hearing Study

Primary Purpose

Hearing Loss, Noise-Induced, Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Advanced
Sponsored by
Apple Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hearing Loss, Noise-Induced focused on measuring Hearing Loss, Noise Exposure, Noise Induced Hearing Loss, Listening Volume, Environmental Noise, Music, Audiometry, Speech-in-Noise, Hearing Ability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan School of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Basic

Advanced

Arm Description

Participants in the first ("Basic") group will have the iOS version 13.2 or later shipping user interface (UI) that provides ability to review exposure level data for headphone audio levels and environmental sound levels in the Health app.

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.

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

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.

Full Information

First Posted
November 13, 2019
Last Updated
February 14, 2022
Sponsor
Apple Inc.
Collaborators
World Health Organization
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1. Study Identification

Unique Protocol Identification Number
NCT04172766
Brief Title
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
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Apple Inc.
Collaborators
World Health Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Noise-Induced, Hearing Loss
Keywords
Hearing Loss, Noise Exposure, Noise Induced Hearing Loss, Listening Volume, Environmental Noise, Music, Audiometry, Speech-in-Noise, Hearing Ability

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Following enrollment in the Apple Hearing Study, participants will be randomly assigned into one of two user groups ("Basic" or "Advanced").
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Basic
Arm Type
No Intervention
Arm Description
Participants in the first ("Basic") group will have the iOS version 13.2 or later shipping user interface (UI) that provides ability to review exposure level data for headphone audio levels and environmental sound levels in the Health app.
Arm Title
Advanced
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Advanced
Intervention Description
"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.
Primary Outcome Measure Information:
Title
Change in headphone audio levels patterns over time
Description
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
Time Frame
Daily, up to 730 days, each compared to baseline
Title
Association between quarterly hearing test results and headphone audio level patterns.
Description
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)
Time Frame
Through study completion, up to 730 days
Secondary Outcome Measure Information:
Title
Acute change in hearing status after headphone audio exposure
Description
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.
Time Frame
0-24 hours after acute headphone exposure, up to twice monthly for up to 2 years
Other Pre-specified Outcome Measures:
Title
Wristwatch-based environmental sound levels patterns
Description
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.
Time Frame
daily up to 730 days
Title
Headphone audio level patterns compared to environmental sound level patterns
Description
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.
Time Frame
daily, for up to 730 days
Title
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
Description
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
Time Frame
through study completion, up to 2 years
Title
Acute change in hearing status after environmental sound exposure
Description
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)
Time Frame
0-24 hours after acute headphone exposure, up to twice monthly for up to 2 years
Title
Association between heart rate patterns and headphone audio level
Description
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.
Time Frame
daily when exercising, for up to 2 years
Title
Association between heart rate patterns and environmental sound level
Description
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.
Time Frame
daily when exercising, for up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Studies Support Center
Phone
833-237-3881
Email
applehearingstudy@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
UM Study Staff
Phone
734-647-1904
Email
applehearingstudy@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Neitzel, PhD, MS, CIH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Public Health
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UM Study Staff
Phone
734-647-1904
Email
applehearingstudy@umich.edu
First Name & Middle Initial & Last Name & Degree
Richard Neitzel, PhD, MS, CIH
First Name & Middle Initial & Last Name & Degree
Lauren M Smith, MS, MPH
First Name & Middle Initial & Last Name & Degree
Glenn E Green, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
N/A - no plan to share
Links:
URL
https://sph.umich.edu/applehearingstudy/
Description
UM Study Website

Learn more about this trial

Apple Hearing Study

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