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OpenTrials
Completed

NCT Number: NCT05350046

Development of Physical Activity Features for Ear-worn Devices

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

Completed

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova Silicon Valley

Fremont, California, 94538, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ear-worn prototype devices

Device

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

Other names: Phonak Audeo

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

57GGardner

Industry

Collaborators

  • Philips BioTelemetry Research
  • Trialfacts

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2022
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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