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Sound Exposure Monitoring for Hearing Loss

N/A

Recruiting

Led By Richard Neitzel, PhD, MS, CIH

Research Sponsored by Apple Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 2 years

Awards & highlights

Study Summary

This trial will help researchers learn how different levels of sound exposure can impact hearing health over time, which could help guide public policy to protect people's hearing.

Who is the study for?

The Apple Hearing Study is open to US residents who are at least 18 years old (with some state-specific age variations), own an iPhone with iOS 13.2 or later, and can communicate in English. Participants should also have the option of owning an Apple Watch Series 4 or newer for additional data collection.Check my eligibility

What is being tested?

Participants will use a special Research app on their iPhones to track sound exposure from headphones and the environment. They'll be split into two groups: one using a 'Basic' interface, and another using an 'Advanced' interface that provides more detailed feedback and requires extra surveys and hearing tests.See study design

What are the potential side effects?

Since this study involves only monitoring sound exposure through an app without any medical interventions, there are no direct side effects associated with participating in this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Association between quarterly hearing test results and headphone audio level patterns.

Change in headphone audio levels patterns over time

Secondary outcome measures

Acute change in hearing status after headphone audio exposure

Other outcome measures

Acute change in hearing status after environmental sound exposure

Association between heart rate patterns and environmental sound level

Association between heart rate patterns and headphone audio level

+3 more

Trial Design

2Treatment groups

Active Control

Group I: BasicActive Control1 Intervention

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.

Group II: AdvancedActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Apple Inc.Lead Sponsor

20 Previous Clinical Trials

1,491,298 Total Patients Enrolled

World Health OrganizationOTHER

233 Previous Clinical Trials

1,416,273 Total Patients Enrolled

Richard Neitzel, PhD, MS, CIHPrincipal Investigator - University of Michigan

University of Michigan

Media Library

Advanced Clinical Trial Eligibility Overview. Trial Name: NCT04172766 — N/A

Hearing Loss Research Study Groups: Basic, Advanced

Hearing Loss Clinical Trial 2023: Advanced Highlights & Side Effects. Trial Name: NCT04172766 — N/A

Advanced 2023 Treatment Timeline for Medical Study. Trial Name: NCT04172766 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial currently have space for new participants?

"Affirmative, the available information from clinicaltrials.gov implies that this research is still recruiting participants. Originally posted on November 14th 2019 and recently edited February 14th 2022, the trial intends to enrol 150 thousand subjects at a single site."

Answered by AI

How many individuals are being admitted to participate in this experiment?

"Affirmative. Clinicaltrials.gov verifies that this medical trial, initially advertised on November 14th 2019 is recruiting patients. A total of 150 thousand volunteers are needed from a single location to complete the study's objectives."

Answered by AI