Clinical trial NCT04680871: Validation of In-Ear Sensor
Official title: Validation of In-Ear Sensor
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Biometrics Measurement
Lead sponsor: Starkey Laboratories, Inc
Sponsor class: INDUSTRY
Collaborators: name: Clinimark, LLC
First posted: 2020-12-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will involve healthy participants 18-50 years of age.

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


Eligibility criteria: 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

Primary outcomes:
measure: Biometric
timeFrame: 1-2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark
state: Colorado
Study officials:
affiliation: Clinimark, LLC
name: Arthur Cabrera, MD
role: PRINCIPAL_INVESTIGATOR
References: