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WithdrawnNCT00361426Updated Jul 19, 2016

EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia Patients

An observational study in COPD Patients, sponsored by EarlySense Ltd.. Withdrawn at 1 site in Israel. Open to participants aged 18 Months and older. Per ClinicalTrials.gov, last updated 2016-07-19.

Sponsored by EarlySense Ltd. · Observational

Why this study was withdrawn
No need
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
0
Ages
18 Months and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • COPD Patients

Keywords

  • COPD
  • Respiration Rate
  • Monitoring
03

In context

Lead sponsor

EarlySense Ltd. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients hospitalized in Med/Surg unit

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

Exclusion Criteria:

  • hospitalization within the passing year
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
0 participants (actual)

Interventions

  • DeviceEarlysense 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

    Also known as: EarlySense system device

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Study locations

1 site
  • Chaim Sheba Medical Center
    Ramat Gan, Israel
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00361426
Lead sponsor
EarlySense Ltd.
Collaborators
The Chaim Sheba Medical Center
Responsible party
Sponsor
First posted
Aug 8, 2006
Start date
Jan 2008
Primary completion
Feb 2009
Completion
Feb 2009
Last update
Jul 19, 2016

Study contacts

Martine Szyper-Kravitz, M.D.
principal investigator · Haim Sheba Medical Center, Israel

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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