Biometrics MeasurementNCT04680871
Validation of In-Ear Sensor
An observational study of Biometrics Measurement, run by Starkey Laboratories, Inc at 1 site in United States.
Trial summary
The purpose of this study is to clinically validate noninvasive in-ear sensor. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Biometrics Measurement
- What is being tested?
- In-Ear Sensor
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 31 Dec 2022
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will involve healthy participants 18-50 years of age.
Who may be able to join
- Subject must have the ability to understand and provide written informed consent
- Subject is an adult over 18 years of age (18 to 50 for Induced Febrile Subjects)
- Subject must be willing and able to comply with study procedures and duration. Subject must be willing and able to comply with study procedures and duration. Must be available for at least 2 visits for ear molds and study conduct.
- Male or female of any race
Who cannot join
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
- Females who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study (For Induced Febrile Subjects only)
- Subjects with known respiratory conditions such as:
- uncontrolled / severe asthma,
- flu,
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- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- respiratory or lung surgery,
- emphysema, COPD, lung disease
- Subjects with self-reported heart or cardiovascular conditions such as:
- Resting high blood pressure: systolic >140 mmHg or diastolic >90 mmHg on 3 consecutive readings (For Induced Febrile Subjects only)
- have had cardiovascular surgery
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke
- transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
- cardiomyopathy
- Self-reported health conditions as identified in the Health Assessment Form
- diabetes,
- thyroid disease (controlled and uncontrolled)
- kidney disease / chronic renal impairment,
- history of seizures (except childhood febrile seizures),
- epilepsy,
- history of unexplained syncope,
- recent history of frequent migraine headaches,
- recent head injury within the last 2 months,
- Cancer / chemotherapy
- Subjects with medical inflammatory conditions/taking antiinflammation medications
- Barbiturates
- Antipsychotics
- Recent immunizations (within 1 month)
- Subjects who have taken antipyretics in the last 240 minutes (aspirin, acetaminophen, ibuprofen)
- Other known health condition, should be considered upon disclosure in health assessment form
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to clinically validate noninvasive in-ear sensor.
- Conditions
- Biometrics Measurement
- Being tested
- In-Ear Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Ear SensorDevice
The device will passively monitor participants' biometrics
| Study group | Role | What they receive |
|---|---|---|
| Normal, Healthy Subjects | Not described Receives: Device: In-Ear Sensor | |
| Induced Febrile Subjects | Not described Receives: Device: In-Ear Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biometric
Biometric data collected from in-ear sensor device and compared to validated reference device
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start4 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Study not being pursued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biometrics MeasurementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Starkey Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
- Investigators
- Arthur Cabrera, MD, Principal investigator, Clinimark, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680871
- Sponsor's protocol ID
- PR 2020-409
- Status last verified
- Dec 2020
- First submitted
- 18 Dec 2020
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of In-Ear Sensor
- ClinicalTrials.gov ID
- NCT04680871
- Acronym / sponsor ID
- PR 2020-409
- Conditions
- Biometrics Measurement
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study not being pursued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Starkey Laboratories, IncIndustry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Dec 2020 (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.
The purpose of this study is to clinically validate noninvasive in-ear sensor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal, Healthy Subjects | – | Device: In-Ear Sensor |
| Induced Febrile Subjects | – | Device: In-Ear Sensor |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will involve healthy participants 18-50 years of age.
Key inclusion criteria (4 listed)
- Subject must have the ability to understand and provide written informed consent
- Subject is an adult over 18 years of age (18 to 50 for Induced Febrile Subjects)
- Subject must be willing and able to comply with study procedures and duration. Subject must be willing and able to comply with study procedures and duration. Must be available for at least 2 visits for ear molds and study conduct.
- Male or female of any race
Key exclusion criteria (41 listed)
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
- Females who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study (For Induced Febrile Subjects only)
- Subjects with known respiratory conditions such as:
- Subjects with self-reported heart or cardiovascular conditions such as:
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 |
|---|---|---|
| In-Ear SensorThe device will passively monitor participants' biometrics | Device | Induced Febrile Subjects, Normal, Healthy Subjects |
Primary outcome
Biometric
Time frame: 1-2 months
Biometric data collected from in-ear sensor device and compared to validated reference device
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- 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.
Arthur Cabrera, MD principal investigator
Clinimark, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biometrics Measurement, run by Starkey Laboratories, Inc 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 4 inclusion and 41 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: withdrawn, as of the sponsor's last update on 9 May 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Biometric (time frame: 1-2 months). 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 9 May 2022.