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EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by EarlySense Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Chaim Sheba Medical Center
Information provided by:
EarlySense Ltd.
ClinicalTrials.gov Identifier:
NCT00361426
First received: August 6, 2006
Last updated: January 24, 2008
Last verified: January 2008
History of Changes
  Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by EarlySense Ltd.:

Estimated Enrollment: 90
Study Start Date: January 2008
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients hospitalized in Med/Surg unit

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361426

Contacts
Contact: Avner Halperin +972-3-7522330 avnerh@earlysense.com
Contact: Hadar Ritte +972-3-7522330 hadarr@earlysense.com

Locations
Israel
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Eyal Zimlichman, M.D.         zimliche@post.tau.ac.il    
Principal Investigator: Eyal Zimlichman, MD            
Sponsors and Collaborators
EarlySense Ltd.
The Chaim Sheba Medical Center
Investigators
Principal Investigator: Martine Szyper-Kravitz, M.D. Haim Sheba Medical Center, Israel
  More Information

No publications provided

Responsible Party: Eyal Zimlichman M.D., Martine Szyper M.D., Chaim Sheba Medical Center Ramat Gan Israel
ClinicalTrials.gov Identifier: NCT00361426     History of Changes
Other Study ID Numbers: 022-05B
Study First Received: August 6, 2006
Last Updated: January 24, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by EarlySense Ltd.:
COPD
Respiration Rate
Monitoring

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013