Validation of In-Ear Sensor

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

Study Overview

• Status: Withdrawn
• Conditions: Biometrics Measurement
• Intervention / Treatment: Device: In-Ear Sensor

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Clinimark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal, Healthy Subjects	Device: In-Ear Sensor; The device will passively monitor participants' biometrics
Induced Febrile Subjects	Device: In-Ear Sensor; The device will passively monitor participants' biometrics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biometric	Biometric data collected from in-ear sensor device and compared to validated reference device	1-2 months

Collaborators and Investigators

• Sponsor: Starkey Laboratories, Inc
• Collaborators: Clinimark, LLC
• Investigators: Principal Investigator: Arthur Cabrera, MD, Clinimark, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PR 2020-409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes