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Eval EarlySense Bet Lowenstein Sleeplab

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ClinicalTrials.gov Identifier: NCT01978340
Recruitment Status : Withdrawn
First Posted : November 7, 2013
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
EarlySense Ltd.

Study Description
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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

Condition or disease
Obese Sleep Apnea, Obstructive Central Apnea Sleep Disorders Poor Quality Sleep

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
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
Study Start Date : November 2013
Estimated Primary Completion Date : February 2014
Actual Study Completion Date : April 2014
Groups and Cohorts
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Group/Cohort
sleeplab
Sleep Lab examined, usualy with some obesity or sleeping disorders.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Responsible Party: EarlySense Ltd.
ClinicalTrials.gov Identifier: NCT01978340     History of Changes
Other Study ID Numbers: ES-CLC-2013_Prot_1
First Posted: November 7, 2013    Key Record Dates
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