Apple Hearing Study

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

Patrocinadores

Patrocinador principal: University of Michigan

Colaborador: World Health Organization

Fuente University of Michigan
Resumen breve

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.

Estado general Recruiting
Fecha de inicio November 14, 2019
Fecha de Terminación December 2021
Fecha de finalización primaria December 2021
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change in headphone audio levels patterns over time Daily, up to 730 days, each compared to baseline
Association between quarterly hearing test results and headphone audio level patterns. Through study completion, up to 730 days
Resultado secundario
Medida Periodo de tiempo
Acute change in hearing status after headphone audio exposure 0-24 hours after acute headphone exposure, up to twice monthly for up to 2 years
Inscripción 150000
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Advanced

Descripción: "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.

Etiqueta de grupo de brazo: Advanced

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Richard Neitzel, PhD, MS, CIH Principal Investigator University of Michigan
Contacto general

Apellido: Research Studies Support Center

Teléfono: 833-237-3881

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Investigador: University of Michigan School of Public Health UM Study Staff 734-647-1904 [email protected] Richard Neitzel, PhD, MS, CIH Principal Investigator Lauren M Smith, MS, MPH Sub-Investigator Glenn E Green, MD Sub-Investigator
Ubicacion Paises

United States

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: University of Michigan

Nombre completo del investigador: Richard Neitzel

Título del investigador: Associate Professor of Environmental Health Sciences and Associate Professor of Global Public Health

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Basic

Tipo: No Intervention

Descripción: 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.

Etiqueta: Advanced

Tipo: Active Comparator

Descripción: 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.

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: Following enrollment in the Apple Hearing Study, participants will be randomly assigned into one of two user groups ("Basic" or "Advanced").

Propósito primario: Basic Science

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov