RECRUITING

Apple Hearing Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-11-14
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04172766

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Live in the United States of America at time of eligibility screening, ascertained from self-report.
  3. * Proficient in written and spoken English, defined by self-report.
  4. * 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.
  5. * Possession of the following, ascertained from automatic hardware/software/device pairing check:
  6. * iPhone with iOS versions capable of supporting the Research app used to complete screening eligibility.
  7. * Optional: Apple Watch (any model) paired with iPhone; an Apple Watch Series 4 or later is required to share environmental sound levels.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Call Center Research Studies Support Center
CONTACT
833-237-3881
applehearingstudy@umich.edu
UM Study Staff
CONTACT
734-647-1904
applehearingstudy@umich.edu

Principal Investigator

Richard L Neitzel, PhD, MS, CIH
PRINCIPAL_INVESTIGATOR
University of Michigan
Lauren M Smith, MS, MPH
STUDY_DIRECTOR
University of Michigan
Joyce M Daniels, MA
STUDY_CHAIR
University of Michigan

Study Locations (Sites)

University of Michigan School of Public Health
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: Apple Inc.

  • Richard L Neitzel, PhD, MS, CIH, PRINCIPAL_INVESTIGATOR, University of Michigan
  • Lauren M Smith, MS, MPH, STUDY_DIRECTOR, University of Michigan
  • Joyce M Daniels, MA, STUDY_CHAIR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-14
Study Completion Date2029-12

Study Record Updates

Study Start Date2019-11-14
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Hearing Loss, Noise-Induced
  • Hearing Loss
  • Tinnitus