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Eval EarlySense Bet Lowenstein Sleeplab

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01978340
First Posted: November 7, 2013
Last Update Posted: July 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
EarlySense Ltd.
  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

Information from the National Library of Medicine

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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:

  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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 24, 2013
First Posted: November 7, 2013
Last Update Posted: July 19, 2016
Last Verified: December 2015

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