NCT00361426

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

July 19, 2016

Status Verified

January 1, 2008

Enrollment Period

1.1 years

First QC Date

August 6, 2006

Last Update Submit

July 17, 2016

Conditions

COPD Patients

Keywords

COPDRespiration RateMonitoring

Interventions

Earlysense vital sign monitorDEVICE

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

Also known as: EarlySense system device

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients hospitalized in Med/Surg unit

You may qualify if:

  • CHF, COPD and Pneumonia Patients or control group non respiratory patients
  • 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

You may not qualify if:

  • hospitalization within the passing year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaim Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martine Szyper-Kravitz, M.D.

    Haim Sheba Medical Center, Israel

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2006

First Posted

August 8, 2006

Study Start

January 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

July 19, 2016

Record last verified: 2008-01

Locations

IL(1)