Eval EarlySense Bet Lowenstein Sleeplab
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
Sleep Apnea, Obstructive
Poor Quality Sleep
|Study Type:||Observational [Patient Registry]|
|Study Design:||Time Perspective: Prospective|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Evaluation of EarlySense - a Contact-less Heart and Respiration Rate Monitor in Hospitalized Patients|
- To determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]the measurements from the EarlySense System will be compared with the "Gold standard" equipment that is being used in the sleep Lab
Biospecimen Retention: None Retained
no Biospeciments will be taken.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Sleep Lab examined, usualy with some obesity or sleeping disorders.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01978340
|Beit Lowenstien||Not yet recruiting|
|Contact: Arie Oxenberg, PhD +972-9-770-9122 firstname.lastname@example.org|
|Principal Investigator: Tatiana Vender, MD|
|Principal Investigator:||Tatiana Vander, MD||Beit Lowenstein Hospital|