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EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia Patients

This study has been withdrawn prior to enrollment.
(No need)
The Chaim Sheba Medical Center
Information provided by (Responsible Party):
EarlySense Ltd. Identifier:
First received: August 6, 2006
Last updated: July 17, 2016
Last verified: January 2008
Continuous measurement of breathing patterns, heart rate, restlessness and cough in sleep using EarlySense ES 16 device. Predicting worsening in COPD patients' condition using the above parameters.

Condition Intervention
COPD Patients
Device: Earlysense vital sign monitor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: EarlySense Monitoring Device Evaluation on Patients in Med / Surg

Further study details as provided by EarlySense Ltd.:

Enrollment: 0
Study Start Date: January 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Earlysense vital sign monitor
    The system is a contactless system that measures heart and respiratory rates and other parameters via a contactless sensor that is placed under the patient mattress
    Other Name: EarlySense system device
Detailed Description:

Study's participants are CHF, COPD and Pneumonia patients or patients who are otherwise hospitalized in internal medicine department. During the study the patients' breathing patterns, heart rate, restlessness and cough in sleep will be measured by the EarlySense ES 16 device, which is placed in the patients' bed.

Patients' clinical status are followed. The patient's clinical condition is followed and analyzed in comparison to the EarlySense system output in order to determine the capability of the EarlySense system to predict COPD, CHF or Pneumonia deteriorations.


Ages Eligible for Study:   18 Months and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients hospitalized in Med/Surg unit

Inclusion Criteria:

  • CHF, COPD and Pneumonia Patients or control group non respiratory patients
  • 18 years old and up
  • Able to perform spirometry test or connect to ECG, respiratory belt, SPO2
  • Willing to sign consent form
  • Home close to Tel Aviv

Exclusion Criteria:

  • hospitalization within the passing year
  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 identifier: NCT00361426

Chaim Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
EarlySense Ltd.
The Chaim Sheba Medical Center
Principal Investigator: Martine Szyper-Kravitz, M.D. Haim Sheba Medical Center, Israel
  More Information

Responsible Party: EarlySense Ltd. Identifier: NCT00361426     History of Changes
Other Study ID Numbers: 022-05B 
Study First Received: August 6, 2006
Last Updated: July 17, 2016
Health Authority: Israel: Ministry of Health

Keywords provided by EarlySense Ltd.:
Respiration Rate
Monitoring processed this record on October 21, 2016