Eval EarlySense Bet Lowenstein Sleeplab
This study has been withdrawn prior to enrollment.
Sponsor:
EarlySense Ltd.
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
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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:
- 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
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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
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 September 30, 2016