Development of Physical Activity Features for Ear-worn Devices

NCT05350046 | Completed DMC FDA Device

• 1 other identifier: SRF-485
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hearing Loss; Well Aging

Outcome Measures

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

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

Study Arms (1)

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.

Device: Ear-worn prototype devices

Interventions

Ear-worn prototype devices DEVICE

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

Also known as: Phonak Audeo

Physically active adults

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 57GGardner: lead
• Philips BioTelemetry Research: collaborator
• Trialfacts: collaborator

Study Sites (1)

Sonova Silicon Valley

Fremont, California, 94538, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Ross, MS

  Sonova USA Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: July 11, 2022
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)