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This study has been withdrawn prior to enrollment.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
  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 ] [ Designated as safety issue: No ]
    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)
Genders Eligible for Study:   Both
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
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
Health Authority: Israel: Ministry of Health

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 July 21, 2016