Hearing Loss Clinical Trial
Official title:
Development of Physical Activity Features for Ear-worn Devices
NCT number | NCT05350046 |
Other study ID # | SRF-485 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 11, 2022 |
Est. completion date | April 24, 2023 |
Verified date | November 2023 |
Source | Sonova AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study incorporates data collection to aid in development of software features related to physical activity for users of ear-worn devices.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Sonova Silicon Valley | Fremont | California |
Lead Sponsor | Collaborator |
---|---|
57GGardner | Philips BioTelemetry Research, Trialfacts |
United States,
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 |
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