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Sound Exposure Monitoring for Hearing Loss (AHS Trial)

N/A

Recruiting

Led By Richard L 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 from enrollment to the end of followup at 10 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 ~ from enrollment to the end of followup at 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the end of followup at 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end of followup at 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Association between Headphone Audio Level patterns and Pure Tone Audiometry

Association between Headphone Audio Level patterns and Speech in Noise

Association between Headphone Audio Level patterns and tinnitus matching

+11 more

Secondary study objectives

Assess reported participant experience

Association between Environmental Sound Level patterns and Pure Tone Audiometry.

Association between Environmental Sound Level patterns and Speech in Noise

+7 more

Other study objectives

Assess novel versions of hearing assessments

Impact of hearing ability on other related aspects of health

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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