Evaluation of EarlySense - a Contact-less Heart and Respiration Rate Monitor in Hospitalized Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- EarlySense Ltd.
- Locations
- 1
- Primary Endpoint
- To determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab
Study Overview
Brief Summary
The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored
Detailed Description
EarlySense sensors will be placed under the mattress of subjects who have been included in the study. The sensors will not be in any contact with the patient. Two sensors will be utilized and placed under the subject's chest and pelvis area. Accuracy of the sensors will be compared to each other and to the reference device.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18 years or above
- •Is willing to sign the consent form
Exclusion Criteria
- •Age < 18 years
- •Is not willing to sign the consent form
Outcomes
Primary Outcomes
To determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab
Time Frame: up to 12 hours
the measurements from the EarlySense System will be compared with the "Gold standard" equipment that is being used in the sleep Lab
Secondary Outcomes
No secondary outcomes reported