Development of Physical Activity Features for Ear-worn Devices

NCT ID: NCT05350046

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-11

Study Completion Date

2023-04-24

Brief Summary

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This study incorporates data collection to aid in development of software features related to physical activity for users of ear-worn devices.

Detailed Description

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This exploratory study involves data collection of adults performing physical activities and activities of daily living for the purpose of comparing data collected by the ear-worn device under test and established gold standard/reference devices and consumer electronic devices. Data collected will be used in the development of software features related to physical activities to benefit the experience of ear-worn device users.

Conditions

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Hearing Loss Well Aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Physically active adults

A cohort of physically-active adults will use ear-worn prototype devices and established gold standard and comparator devices during rest periods, physical activity, and various activities of daily living.

Group Type EXPERIMENTAL

Ear-worn prototype devices

Intervention Type DEVICE

Hearing instrument including sensors to track movement and estimations of biological information.

Interventions

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Ear-worn prototype devices

Hearing instrument including sensors to track movement and estimations of biological information.

Intervention Type DEVICE

Other Intervention Names

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Phonak Audeo

Eligibility Criteria

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Inclusion Criteria

* Age 40 - 85
* Minimum height 5'3"
* Fully vaccinated against Covid -19
* Willing and able perform various exercise activities at a light and moderate relative intensity, such as riding a stationary bike, walking and jogging on a treadmill, and performing squatting movements.
* Non-smoker for the past 6 months.
* Willing to abstain from caffeine and alcohol 6 hours before participation.
* Willing to fast from eating 4 hours before participation.

Exclusion Criteria

* History of chronic heart disease or significant cardiac events (e.g. cardiac arrythmia).
* Diagnosed with diabetes mellitus or other metabolic disorder.
* History of cerebral vascular accident.
* History of pulmonary disorder.
* Experiencing orthopedic injury or disorders that restrict movement or cause painful physical activity.
* History of neurodegenerative or neuromuscular pathology.
* Advised by a healthcare professional to not participate in physical activity.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philips BioTelemetry Research

UNKNOWN

Sponsor Role collaborator

Trialfacts

UNKNOWN

Sponsor Role collaborator

57GGardner

INDUSTRY

Sponsor Role lead

Responsible Party

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57GGardner

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christopher Ross, MS

Role: STUDY_DIRECTOR

Sonova USA Inc

Locations

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Sonova Silicon Valley

Fremont, California, United States

Site Status

Countries

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United States

Other Identifiers

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SRF-485

Identifier Type: -

Identifier Source: org_study_id