Eval EarlySense Bet Lowenstein Sleeplab

Withdrawn

• Conditions: Sleep Apnea, Obstructive; Central Apnea; Sleep Disorders; Obese; Poor Quality Sleep

• Registration Number: NCT01978340
• Lead Sponsor: EarlySense Ltd.

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 Timeline

• Study First Submitted: 2013-06-24
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-07
• Primary Completion: 2014-02
• Study Completion: 2014-04
• Status Verified: 2015-12
• Last Update Submitted: 2016-07-17
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age 18 years or above
2. Is willing to sign the consent form

Exclusion Criteria

1. Age < 18 years
2. Is not willing to sign the consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab	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

Trial Locations

Locations (1)

Beit Lowenstien; 🇮🇱 Raa'nana, Israel