Back to resultsDevelopment of Physical Activity Features for Ear-worn Devices
Primary Purpose
Hearing Loss, Well Aging
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ear-worn prototype devices
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss
Eligibility Criteria
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.
Sites / Locations
- Sonova Silicon ValleyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physically active adults
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05350046
First Posted
April 21, 2022
Last Updated
September 27, 2022
Sponsor
57GGardner
Collaborators
Philips BioTelemetry Research, Trialfacts
1. Study Identification
Unique Protocol Identification Number
NCT05350046
Brief Title
Development of Physical Activity Features for Ear-worn Devices
Official Title
Development of Physical Activity Features for Ear-worn Devices
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
57GGardner
Collaborators
Philips BioTelemetry Research, Trialfacts
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study incorporates data collection to aid in development of software features related to physical activity for users of ear-worn devices.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Well Aging
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physically active adults
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ear-worn prototype devices
Other Intervention Name(s)
Phonak Audeo
Intervention Description
Hearing instrument including sensors to track movement and estimations of biological information.
Primary Outcome Measure Information:
Title
Accuracy of ear-worn device information
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nilda Balano
Phone
510-743-3970
Email
sv.clinical@sonova.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Ross, MS
Organizational Affiliation
Sonova USA Inc
Official's Role
Study Director
Facility Information:
Facility Name
Sonova Silicon Valley
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nilda Balano
Phone
510-743-3970
Email
sv.clinical@sonova.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of Physical Activity Features for Ear-worn Devices
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