Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data
2019년 1월 22일 업데이트: 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.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ohio
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Cincinnati, Ohio, 미국, 45212
- CTI Clinical Research Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device
기간: 2 days after informed consent
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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
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Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device
기간: 2 days after informed consent
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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
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Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device
기간: 2 days after informed consent
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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
기간: 2 days after informed consent
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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
기간: 2 days after informed consent
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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
기간: 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
기간: 2 days after informed consent
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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
기간: 2 days after informed consent
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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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 7월 31일
기본 완료 (실제)
2017년 8월 25일
연구 완료 (실제)
2017년 8월 30일
연구 등록 날짜
최초 제출
2017년 8월 16일
QC 기준을 충족하는 최초 제출
2017년 8월 17일
처음 게시됨 (실제)
2017년 8월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 1월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 1월 22일
마지막으로 확인됨
2019년 1월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- MC10-PTL-103
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Physiological signal monitor에 대한 임상 시험
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Promedius Inc모병
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Erasme University Hospital아직 모집하지 않음