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OpenTrials
Completed

NCT Number: NCT03257189

Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data

Study objective: The primary objective of the clinical investigation is to evaluate the accuracy of BioStamp nPoint system algorithm measurements.

Study design: A single-site, non-significant risk, open-label, prospective non-randomized clinical investigation designed to validate the accuracy of the various physiological parameters that the Wearable Sensor Patches acquire and the system processes.

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Key information

Conditions

Healthy Normals

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female volunteers, at least 18 years of age at the time of screening visit;
  • Fluent in English;
  • The subject is willing to comply with the protocol specified evaluations;
  • Subject is willing and cognitively able to sign informed consent

Exclusion criteria

  • Pregnancy;
  • Positive urine drug screen
  • History of active (clinically significant) skin disorders;
  • History of allergic response to silicones or adhesives;
  • Subjects with electronic implants of any kind (e.g. pacemaker)
  • History of sleep disorders or self-reported insomnia or other sleep conditions;
  • Broken, damaged or irritated skin or rashes near the sensor application sites;
  • Subjects that are MC10 employees or shareholders, or a spouse or child of an MC10 employee or shareholder;
  • Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.

Treatment and study plan

Physiological signal monitor

Device

Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.

Heart rate and heart rate variability comparison device

Device

FDA cleared reference device that monitors heart rate and heart rate variability in subjects

Respiration rate comparison device

Device

FDA cleared reference device that monitors respiration rate in subjects

Activity classification

Other

Visual annotation of subject posture and other activities used for reference

Primary outcomes

  1. Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device

    Time frame: 2 days after informed consent

    Heart rate as measured by the subject device in beats per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.

  2. Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device

    Time frame: 2 days after informed consent

    Heart Rate Variability RMSSD is measured by the subject device determined by root mean square of successive differences in neighboring RR intervals and will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.

  3. Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device

    Time frame: 2 days after informed consent

    HRV Ratio as measured by the subject device determined by low frequency content to high frequency content ratio (HRV Ratio) in beats per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.

  4. Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device

    Time frame: 2 days after informed consent

    Respiration rate as measured by the subject device in breaths per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.

  5. Accuracy of Activity Classification as Compared to Visual Annotation

    Time frame: 2 days after informed consent

    The device under test will classify a subjects activity into sleeping, standing, sitting, lying, walking and other activities as the subject performs various predefined activities, which are annotated by an observer. The device's Activity Classification will be compared to the observer's annotation. The percentage of correct classifications by the device against indicated visual observation is presented. The percent correct is not a per subject average, but is the percentage of all activity classifications which were correct when compared to ground truth observation.

  6. Accuracy of Step Count Compared to an Observer's Manual Count

    Time frame: 2 days after informed consent

    The number of steps reported by the device under test during a 6 minute walk test will be compared to an observer's manual count of the number of steps taken.

  7. Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation

    Time frame: 2 days after informed consent

    Sleep onset and wake times as reported by the device under test will be compared to an observer's visual annotation of the sleep onset and wake times. The Mean Absolute Error (MAE) between times as indicated by the device and observed times is presented.

  8. Accuracy of Posture Classification as Compared to Visual Annotation

    Time frame: 2 days after informed consent

    The device under test will classify a subjects activity into sleep posture, standing posture, and sitting posture as the subject performs various predefined activities, which are annotated by an observer. The device's Posture Classification will be compared to the observer's annotation. The percentage of correct classifications by the device against indicated visual observation is presented. The percent correct is not a per subject average, but is the percentage of all posture classifications which were correct when compared to ground truth observation.

  9. Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale

    Time frame: 2 days after informed consent

    The level of sensor adhesion will be assessed by a 5 point scale (0- sensor is greater than or equal to 90% of sensor adhered, 4-sensor completely detached from subject). Sensors receiving scores of 0 and 1 will be determined to have acceptable adhesion, while scores of 2, 3, and 4 will be considered unacceptable adhesion. The percentage of sensors which had acceptable adhesion at sensor removal is presented.

Sponsors and collaborators

Lead sponsor

MC10 Inc.

Industry

Registry information

Official study title

A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data in Healthcare and Remote Settings

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 22, 2017
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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