NCT01978340

Eval EarlySense Bet Lowenstein Sleeplab

Evaluation of EarlySense - a Contact-less Heart and Respiration Rate Monitor in Hospitalized Patients

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: EarlySense Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obese
• Sleep Apnea, Obstructive
• Central Apnea
• Sleep Disorders
• Poor Quality Sleep

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-02-01
• Completion: 2014-04-01
• First posted: 2013-11-07
• Last updated: 2016-07-19

Locations

1 site across 1 country: Israel