EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia Patients

Withdrawn

• Conditions: COPD Patients

• Registration Number: NCT00361426
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2006-08-06
• Study First Submitted QC: 2006-08-06
• Study First Posted: 2006-08-08
• Status Verified: 2008-01
• Study Start: 2008-01
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2016-07-17
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Chaim Sheba Medical Center; 🇮🇱 Ramat Gan, Israel