Accuracy Assessment of Beddr Oximeter

Completed

• Conditions: Oximetry

• Registration Number: NCT03710993
• Lead Sponsor: Hancock Medical, Inc.

Brief Summary

Accuracy performance of Beddr oximeter

Detailed Description

This study will evaluate the accuracy of the Beddr sleepTuner oximeter compared to a transfer standard and multiple reference devices.

Study Timeline

• Study Start: 2018-07-30
• Primary Completion: 2018-08-03
• Study Completion: 2018-08-03
• Status Verified: 2018-10
• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-10-16
• Last Update Submitted: 2018-10-16
• Study First Posted: 2018-10-18
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Subject must have the ability to understand and provide written informed consent
• Adult subjects 18 up to 50 years of age
• Subject must be willing and able to comply with study procedures and duration
• Subject is a non-smoker or who has not smoked within 2 days prior to the study.
• Male or female of any race
• Subject demographics include a range of skin pigmentations, including at least 1 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

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

• Subjects with known respiratory conditions such as:

  • uncontrolled / severe asthma,
  • flu,
  • pneumonia / bronchitis,
  • shortness of breath / respiratory distress,
  • unresolved respiratory or lung surgery with continued indications of health issues,
  • emphysema, COPD, lung disease

• Subjects with known heart or cardiovascular conditions such as:

  • Hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings.
  • 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,
  • uncontrolled thyroid disease,
  • 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 known clotting disorders

  • history of bleeding disorders or personal history of prolonged bleeding from injury
  • history of blood clots
  • hemophilia
  • current use of blood thinner: prescription or daily use of aspirin

• Subjects with Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors

• Unwillingness or inability to remove colored nail polish or non-clear artificial nails from test digits.

• Other known health condition, should be considered upon disclosure in health assessment form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SpO2 accuracy	60 minutes	Collect and analyze data to assess SpO2 calibration and accuracy

Trial Locations

Locations (1)

Clinimark; 🇺🇸 Louisville, Colorado, United States