Development of Physical Activity Features for Ear-worn Devices

Hearing Loss Clinical Trial

Official title:

Development of Physical Activity Features for Ear-worn Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05350046
• Other study ID #: SRF-485
• Status: Completed
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: April 24, 2023

Study information

• Verified date: November 2023
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss
• Well Aging

Intervention

Device:
• Ear-worn prototype devices
Hearing instrument including sensors to track movement and estimations of biological information.

Locations

Country	Name	City	State
United States	Sonova Silicon Valley	Fremont	California

Sponsors (3)

Lead Sponsor	Collaborator
57GGardner	Philips BioTelemetry Research, Trialfacts

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	data collection during activities ranging in duration from 5-20 minutes