ClinicalTrials.gov
ClinicalTrials.gov Menu

EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00361426
Recruitment Status : Withdrawn (No need)
First Posted : August 8, 2006
Last Update Posted : July 19, 2016
Sponsor:
Collaborator:
The Chaim Sheba Medical Center
Information provided by (Responsible Party):
EarlySense Ltd.

Brief Summary:
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 or disease Intervention/treatment
COPD Patients Device: Earlysense vital sign monitor

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.


Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: EarlySense Monitoring Device Evaluation on Patients in Med / Surg
Study Start Date : January 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361426


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

Responsible Party: EarlySense Ltd.
ClinicalTrials.gov Identifier: NCT00361426     History of Changes
Other Study ID Numbers: 022-05B
First Posted: August 8, 2006    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: January 2008

Keywords provided by EarlySense Ltd.:
COPD
Respiration Rate
Monitoring