Eval EarlySense Bet Lowenstein Sleeplab

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by EarlySense Ltd.
Sponsor:
Information provided by (Responsible Party):
EarlySense Ltd.
ClinicalTrials.gov Identifier:
NCT01978340
First received: June 24, 2013
Last updated: November 6, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


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.


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated 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
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 Not yet recruiting
Raa'nana, Israel
Contact: Arie Oxenberg, PhD    +972-9-770-9122    arie0@clalit.org.il   
Principal Investigator: Tatiana Vender, MD         
Sponsors and Collaborators
EarlySense Ltd.
Investigators
Principal Investigator: Tatiana Vander, MD Beit Lowenstein Hospital
  More Information

No publications provided

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: November 6, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Disorders
Parasomnias
Sleep Apnea, Obstructive
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014