Eval EarlySense Bet Lowenstein Sleeplab

NCT ID: NCT01978340

Last Updated: 2016-07-19

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-04-30

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.

Conditions

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

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

sleeplab

Sleep Lab examined, usualy with some obesity or sleeping disorders.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EarlySense Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tatiana Vander, MD

Role: PRINCIPAL_INVESTIGATOR

Beit Lowenstein Hospital

Locations

Beit Lowenstien

Raa'nana, , Israel

Countries

Israel

Other Identifiers

ES-CLC-2013_Prot_1

Identifier Type: -

Identifier Source: org_study_id