EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia Patients

NCT ID: NCT00361426

Last Updated: 2016-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-02-28

Brief Summary

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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

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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.

Conditions

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COPD Patients

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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EarlySense system device

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Chaim Sheba Medical Center

OTHER

Sponsor Role collaborator

EarlySense Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martine Szyper-Kravitz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Haim Sheba Medical Center, Israel

Locations

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Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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022-05B

Identifier Type: -

Identifier Source: org_study_id

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