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Trial record 36 of 634 for:    oximeter

Accuracy Assessment of Beddr Oximeter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03710993
Recruitment Status : Completed
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Information provided by (Responsible Party):
Hancock Medical, Inc.

Brief Summary:
Accuracy performance of Beddr oximeter

Condition or disease Intervention/treatment
Oximetry Device: oximeter

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

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Beddr Sleep SpO2 Equivalency Calibration Study
Actual Study Start Date : July 30, 2018
Actual Primary Completion Date : August 3, 2018
Actual Study Completion Date : August 3, 2018

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. SpO2 accuracy [ Time Frame: 60 minutes ]
    Collect and analyze data to assess SpO2 calibration and accuracy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy adult volunteers, ranging in pigmentation from light to dark.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03710993

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United States, Colorado
Louisville, Colorado, United States, 80027
Sponsors and Collaborators
Hancock Medical, Inc.
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Principal Investigator: Arthur Cabrera, MD Clinimark, LLC

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Responsible Party: Hancock Medical, Inc. Identifier: NCT03710993     History of Changes
Other Study ID Numbers: PR 2018-290
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No