Development of Physical Activity Features for Ear-worn Devices

57GGardner

Status: Completed

Conditions: Well Aging; Hearing Loss

Treatments: Device: Ear-worn prototype devices

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05350046

SRF-485

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Physically active adults

Experimental group

Description:

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.

Treatment:

Device: Ear-worn prototype devices