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

22 januari 2019 uppdaterad av: MC10 Inc.

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45212
        • CTI Clinical Research Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 99 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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.
Enhet: Physiological signal monitor
Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.
Enhet: Heart rate and heart rate variability comparison device
FDA cleared reference device that monitors heart rate and heart rate variability in subjects
Enhet: Respiration rate comparison device
FDA cleared reference device that monitors respiration rate in subjects
Övrig: Activity classification
Visual annotation of subject posture and other activities used for reference

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device
Tidsram: 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 days after informed consent
Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device
Tidsram: 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.
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
Tidsram: 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.
2 days after informed consent
Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device
Tidsram: 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.
2 days after informed consent
Accuracy of Activity Classification as Compared to Visual Annotation
Tidsram: 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.
2 days after informed consent
Accuracy of Step Count Compared to an Observer's Manual Count
Tidsram: 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.
2 days after informed consent
Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation
Tidsram: 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.
2 days after informed consent
Accuracy of Posture Classification as Compared to Visual Annotation
Tidsram: 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.
2 days after informed consent
Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale
Tidsram: 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.
2 days after informed consent

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

MC10 Inc.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

31 juli 2017

Primärt slutförande (Faktisk)

25 augusti 2017

Avslutad studie (Faktisk)

30 augusti 2017

Studieregistreringsdatum

Först inskickad

16 augusti 2017

Först inskickad som uppfyllde QC-kriterierna

17 augusti 2017

Första postat (Faktisk)

22 augusti 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 januari 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 januari 2019

Senast verifierad

1 januari 2019

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • MC10-PTL-103

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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