Development of Physical Activity Features for Ear-worn Devices

November 30, 2023 updated by: 57GGardner
This study incorporates data collection to aid in development of software features related to physical activity for users of ear-worn devices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Fremont, California, United States, 94538
        • Sonova Silicon Valley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Ear-worn prototype devices
Hearing instrument including sensors to track movement and estimations of biological information.
Other Names:
  • Phonak Audeo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
data collection during activities ranging in duration from 5-20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

57GGardner

Collaborators

Trialfacts
Philips BioTelemetry Research

Investigators

  • Study Director: Christopher Ross, MS, Sonova USA Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2022

Primary Completion (Actual)

April 24, 2023

Study Completion (Actual)

April 24, 2023

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-485

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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