Skip to main content
Clinical Trials/NCT05350046
NCT05350046CompletedNot Applicable

Development of Physical Activity Features for Ear-worn Devices

57GGardner1 site in 1 country30 target enrollmentStarted: July 11, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Accuracy of ear-worn device information

Study Overview

Brief Summary

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

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Physically active adults

Experimental

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.

Intervention: Ear-worn prototype devices (Device)

Outcomes

Primary Outcomes

Accuracy of ear-worn device information

Time Frame: data collection during activities ranging in duration from 5-20 minutes

Accuracy of information provided by the ear-worn device in comparison to the comparator devices using mean absolute percentage error calculations

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
57GGardner
Sponsor Class
Industry
Responsible Party
Sponsor Investigator
Principal Investigator

57GGardner

Principal Investigator

Sonova AG

Study Sites (1)

Loading locations...

Similar Trials