Accuracy Evaluation of EarlySense With Modified Sensor (Smaller Shape

Status Not yet recruiting

Clinical Trial Summary

Accuracy evaluation of EarlySense device, a smaller shape sensor with BLE connection to processing unit (HUB)) for use while two people are in bed ("Home Use" scenario) The EarlySense device is intended for continuous contact-free monitoring of heart rate and respiration rate at home, or in professional healthcare settings. The system is intended for remote monitoring of patients by healthcare professionals and is indicated mainly for elderly population monitoring. The modified version of this product which is the subject of this validation study allows monitoring of subjects when there is a second person in the same bed ("Home scenario" environment). The objective of this study is to evaluate the accuracy of the device in determining Respiration Rate (Br./min) and Heart Rate (BPM) at home environment, while two people are in the same double bed. The study aims to demonstrate that partner presence doesn't affect the monitoring accuracy of the subject that is being measured. The continuous monitoring will last for duration of 90 minutes for each subject, unless the participant requests termination of the experiment or as per the physician's instructions. Subjects admitted to the study will be monitored using both Capnography and ECG- as reference devices. The EarlySense revised sensor will be placed under one of the two-mattress types incorporated into the study. Both mattresses are typical double bed mattresses of 160 X 200 cm with two different internal structure composition. The sensor will be placed directly below the subject's thorax area on one of the mattress sides. The signals collected by the sensor will be communicated via BLE to the processing unit (HUB). Following connecting the subject to the reference devices, both the subject and the partner will be instructed on the actions they should perform through the stages of the experiment. The subject will lie on the mattress side where the EarlySense sensor is located, while the partner will be instructed to enter the other side of the mattress. At this time, the experiment will start, and the clock will start running.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05237518
Study type	Interventional
Source	EarlySense Ltd.
Contact
Status	Not yet recruiting
Phase	N/A
Start date	April 2023
Completion date	April 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Accuracy Evaluation of EarlySense With Modified Sensor (Smaller Shape Sensor With BLE) at Home Setting Monitoring a Subject While Partner in Bed

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms