Eval EarlySense Bet Lowenstein Sleeplab

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

EarlySense Ltd.

ClinicalTrials.gov Identifier:

NCT01978340

First received: June 24, 2013

Last updated: July 17, 2016

Last verified: December 2015

History of Changes

Purpose

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

Condition
Obese Sleep Apnea, Obstructive Central Apnea Sleep Disorders 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

Further study details as provided by EarlySense Ltd.:

Primary Outcome Measures:

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

Biospecimen Retention: None Retained

no Biospeciments will be taken.


Enrollment:	0
Study Start Date:	November 2013
Study Completion Date:	April 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
sleeplab Sleep Lab examined, usualy with some obesity or sleeping disorders.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Different patient population will be monitored including obese, morbidly obese, patients with or without apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01978340

Locations


Israel
Beit Lowenstien
Raa'nana, Israel

Sponsors and Collaborators

EarlySense Ltd.

Investigators


Principal Investigator:	Tatiana Vander, MD	Beit Lowenstein Hospital

More Information


Responsible Party:	EarlySense Ltd.
ClinicalTrials.gov Identifier:	NCT01978340 History of Changes
Other Study ID Numbers:	ES-CLC-2013_Prot_1
Study First Received:	June 24, 2013
Last Updated:	July 17, 2016

Additional relevant MeSH terms:


Apnea Sleep Wake Disorders Parasomnias Sleep Apnea, Obstructive Sleep Apnea, Central Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory	Signs and Symptoms Nervous System Diseases Neurologic Manifestations Mental Disorders Sleep Apnea Syndromes Sleep Disorders, Intrinsic Dyssomnias

ClinicalTrials.gov processed this record on September 21, 2017

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