NCT03257189

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

Completed NA Results posted Last updated 25 January 2019

What this trial tests

NA trial testing Physiological signal monitor in Healthy Normals in 30 participants. Completed in 30 August 2017.

Timeline

31 July 2017

Primary endpoint
25 August 2017

30 August 2017

Quick facts

Lead sponsor	MC10 Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	30
Start date	31 July 2017
Primary completion	25 August 2017
Estimated completion	30 August 2017
Sites	1 location across United States

Drugs / interventions tested

• Physiological signal monitor
• Heart rate and heart rate variability comparison device
• Respiration rate comparison device
• Activity classification

Conditions studied

• Healthy Normals — all drugs for Healthy Normals →

Sponsor

MC10 Inc.

Who can join

Adults 18 to 99, any sex, with Healthy Normals. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Device Monitoring	2.0	± 5.1

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

Group	Value	95% CI
Device Monitoring	5.1	± 24.9

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

Group	Value	95% CI
Device Monitoring	1.1	± 1.8

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

Group	Value	95% CI
Device Monitoring	1.3	± 2.1

Accuracy of Activity Classification as Compared to Visual Annotation Primary · 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.

Group	Value	95% CI
Device Monitoring	98.7

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

Group	Value	95% CI
Device Monitoring	2.4	± 1.9

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

Sleep Onset

Group	Value	95% CI
Device Monitoring	6.8	± 8.43

Sleep Wake

Group	Value	95% CI
Device Monitoring	11.5	± 28.5

Accuracy of Posture Classification as Compared to Visual Annotation Primary · 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.

Group	Value	95% CI
Device Monitoring	92.9

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

All Sensors

Group	Value	95% CI
Device Monitoring	83

Sensors for Algorithm Outputs (Chest and Thigh)

Group	Value	95% CI
Device Monitoring	92

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was available for collection for 3 days after the subject left the clinic. Subjects were evaluated throughout their 3 days at the clinic and a safety follow up phone call was conducted 3 days after their last clinic visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Device Monitoring

Serious: 0/30 (0%)

Deaths: 0/30

Other adverse events (1 terms — click to expand)

Reaction	System	Device Monitoring
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT03257189 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.