Validation of In-Ear Sensor

NCT04680871 | Withdrawn FDA Device

• 1 other identifier: PR 2020-409
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Biometrics Measurement

Outcome Measures

Primary Outcomes (1)

• Biometric

  Biometric data collected from in-ear sensor device and compared to validated reference device

  1-2 months

Study Arms (2)

Normal, Healthy Subjects

Device: In-Ear Sensor

Induced Febrile Subjects

Device: In-Ear Sensor

Interventions

In-Ear Sensor DEVICE

The device will passively monitor participants' biometrics

Induced Febrile Subjects; Normal, Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will involve healthy participants 18-50 years of age.

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

Sponsors & Collaborators

• Starkey Laboratories, Inc: lead
• Clinimark, LLC: collaborator

Study Sites (1)

Clinimark

Louisville, Colorado, 80027, United States

Location

Study Officials

• Arthur Cabrera, MD

  Clinimark, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: January 4, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 9, 2022

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)