COPD PatientsNCT00361426
EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia Patients
An observational study of COPD Patients, run by EarlySense Ltd. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- COPD Patients
- What is being tested?
- Earlysense vital sign monitor
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized in Med/Surg unit
Who may be able to join
- 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
Who cannot join
- hospitalization within the passing year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EarlySense Monitoring Device Evaluation on Patients in Med / Surg
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.
- Conditions
- COPD Patients
- Being tested
- Earlysense vital sign monitor
- Keywords
- COPD, Respiration Rate, Monitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Earlysense vital sign monitorDevice
Also called EarlySense system device
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startJan 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: No need
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EarlySense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Chaim Sheba Medical Center
- Responsible party
- Sponsor
- Investigators
- Martine Szyper-Kravitz, M.D., Principal investigator, Haim Sheba Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361426
- Sponsor's protocol ID
- 022-05B
- Status last verified
- Jan 2008
- First submitted
- 6 Aug 2006
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EarlySense Monitoring Device Evaluation on Patients in Med / Surg
- ClinicalTrials.gov ID
- NCT00361426
- Acronym / sponsor ID
- 022-05B
- Conditions
- COPD Patients
- Keywords
- COPD, Respiration Rate, Monitoring
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No need
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EarlySense Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Chaim Sheba Medical Center
- Study start
- Jan 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in Med/Surg unit
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- hospitalization within the passing year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Earlysense vital sign monitorAlso: EarlySense system deviceThe 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 | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Szyper-Kravitz, M.D. principal investigator
Haim Sheba Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Patients, run by EarlySense Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.