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- Klinische proef NCT03257189
Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data
A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data in Healthcare and Remote Settings
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45212
- CTI Clinical Research Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Ander: Single Arm
This single arm consists of all subjects which will interact with the device under investigation as well as comparator devices. This includes the Physiological signal monitor intervention, Heart rate and heart rate variability comparison device intervention, Respiration rate comparison device intervention, and Activity classification intervention. |
Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.
FDA cleared reference device that monitors heart rate and heart rate variability in subjects
FDA cleared reference device that monitors respiration rate in subjects
Visual annotation of subject posture and other activities used for reference
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device
Tijdsspanne: 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.
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2 days after informed consent
|
Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device
Tijdsspanne: 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.
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2 days after informed consent
|
Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device
Tijdsspanne: 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.
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2 days after informed consent
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Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device
Tijdsspanne: 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.
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2 days after informed consent
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Accuracy of Activity Classification as Compared to Visual Annotation
Tijdsspanne: 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.
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2 days after informed consent
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Accuracy of Step Count Compared to an Observer's Manual Count
Tijdsspanne: 2 days after informed consent
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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.
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2 days after informed consent
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Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation
Tijdsspanne: 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.
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2 days after informed consent
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Accuracy of Posture Classification as Compared to Visual Annotation
Tijdsspanne: 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.
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2 days after informed consent
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Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale
Tijdsspanne: 2 days after informed consent
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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.
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2 days after informed consent
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- MC10-PTL-103
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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