CClinicalTrials.gg
CompletedNCT05350046Updated Dec 4, 2023

Development of Physical Activity Features for Ear-worn Devices

An interventional study of Ear-worn prototype devices in Hearing Loss and Well Aging, sponsored by 57GGardner. Completed at 1 site in United States. Open to participants aged 40 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-04.

Sponsored by 57GGardner · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was Apr 2023, 3 years 5 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
40 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hearing Loss
  • Well Aging

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03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

This is the only study on the registry with 57GGardner as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • DeviceEar-worn prototype devices

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

    Also known as: Phonak Audeo

06

What researchers measure

Primary outcomes

  1. 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

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

07

Study locations

1 site
  • Sonova Silicon Valley
    Fremont, California 94538, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05350046
Lead sponsor
57GGardner
Collaborators
Philips BioTelemetry Research, Trialfacts
Responsible party
57GGardner (Principal Investigator, Sonova AG) — Sponsor-investigator
First posted
Apr 27, 2022
Start date
Jul 11, 2022
Primary completion
Apr 24, 2023
Completion
Apr 24, 2023
Last update
Dec 4, 2023

Study contacts

Christopher Ross, MS
study director · Sonova USA Inc

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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