Development of Physical Activity Features for Ear-worn Devices

Study Overview
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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.

Official Title
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Development of Physical Activity Features for Ear-worn Devices

Conditions
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Hearing Loss, Well Aging

Intervention / Treatment
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* Device: Ear-worn prototype devices


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physically active adults<br>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. | Device: Ear-worn prototype devices<br>* Hearing instrument including sensors to track movement and estimations of biological information.<br>* Other names: Phonak Audeo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of ear-worn device information | Accuracy of information provided by the ear-worn device in comparison to the comparator devices using mean absolute percentage error calculations | data collection during activities ranging in duration from 5-20 minutes |