Validation of In-Ear Sensor

Withdrawn before enrolling

Conditions studied: Biometrics Measurement

In brief

The purpose of this study is to clinically validate noninvasive in-ear sensor.

Key facts

Study ID

NCT04680871

Run by

Starkey Laboratories, Inc

People needed

0

Starts

2022-01-04

Expected to finish

2022-12-31

Last updated by the study team

2022-05-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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,
• 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

Where it is running

• Clinimark — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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