EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia Patients

COPD Patients Clinical Trial

Official title:

EarlySense Monitoring Device Evaluation on Patients in Med / Surg

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00361426
• Other study ID #: 022-05B
• Status: Withdrawn
• Phase: N/A
• First received: August 6, 2006
• Last updated: July 17, 2016
• Start date: January 2008
• Est. completion date: February 2009

Study information

• Verified date: January 2008
• Source: EarlySense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD Patients

Intervention

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

Locations

Country	Name	City	State
Israel	Chaim Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
EarlySense Ltd.	The Chaim Sheba Medical Center

Country where clinical trial is conducted

Israel,