Accuracy Assessment of Beddr Oximeter

NCT ID: NCT03710993

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-30
• Study Completion Date: 2018-08-03

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.

Conditions

Oximetry

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

oximeter

Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding transfer standard and reference devices to assess oximeter calibration and accuracy.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hancock Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur Cabrera, MD

Role: PRINCIPAL_INVESTIGATOR

Clinimark, LLC

Locations

Clinimark

Louisville, Colorado, United States

Countries

United States

Other Identifiers

PR 2018-290

Identifier Type: -

Identifier Source: org_study_id