Hearing LossNCT05350046
Development of Physical Activity Features for Ear-worn Devices
A study testing Ear-worn prototype devices in people with Hearing Loss and Well Aging, run by 57GGardner at 1 site in United States.
Trial summary
This study incorporates data collection to aid in development of software features related to physical activity for users of ear-worn devices. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Well Aging
- What is being tested?
- Ear-worn prototype devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 24 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study incorporates data collection to aid in development of software features related to physical activity for users of ear-worn devices.
Read the 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.
- Conditions
- Hearing Loss, Well Aging
- Being tested
- Ear-worn prototype devices
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear-worn prototype devicesDevice
Also called Phonak Audeo
Hearing instrument including sensors to track movement and estimations of biological information.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ear-worn prototype devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: data collection during activities ranging in duration from 5-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start11 Jul 2022
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- 57GGardner
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philips BioTelemetry Research, Trialfacts
- Responsible party
- Sponsor-investigator, 57GGardner, Sonova AG
- Investigators
- Christopher Ross, MS, Study director, Sonova USA Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350046
- Sponsor's protocol ID
- SRF-485
- Status last verified
- Nov 2023
- First submitted
- 21 Apr 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Physical Activity Features for Ear-worn Devices
- ClinicalTrials.gov ID
- NCT05350046
- Acronym / sponsor ID
- SRF-485
- Conditions
- Hearing Loss, Well Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- 57GGardnerIndustry (pharma, biotech, devices)
- Collaborators
- Philips BioTelemetry Research, Trialfacts
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physically active adults | Experimental | Device: Ear-worn prototype devicesA 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ear-worn prototype devicesAlso: Phonak AudeoHearing instrument including sensors to track movement and estimations of biological information. | Device | Physically active adults |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Ross, MS study director
Sonova USA Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ear-worn prototype devices in people with Hearing Loss and Well Aging, run by 57GGardner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of ear-worn device information (time frame: data collection during activities ranging in duration from 5-20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.