Accuracy Assessment of Beddr Oximeter

Study Overview
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Brief Summary
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Accuracy performance of Beddr oximeter

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

Official Title
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Beddr Sleep SpO2 Equivalency Calibration Study

Conditions
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Oximetry

Intervention / Treatment
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* Device: oximeter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SpO2 accuracy | Collect and analyze data to assess SpO2 calibration and accuracy | 60 minutes |