Over WeightNCT02036996
Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined
An observational study of Over Weight and Sleep Disorders, run by EarlySense Ltd. at 1 site in Israel.
Trial summary
The objective of this study is to collect heart rate, respiration data and motion data of patients admitted to sleep lab and to determine the current accuracy level of the EarlySense system vs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Over Weight, Sleep Disorders
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Dec 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Different patient population will be monitored including obese, morbidly obese, patients with or without apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored
Who may be able to join
- 1. Age 18 years or more 2. Is willing to sign the consent form.
Who cannot join
- Age < 18 years
- Is not willing to sign the consent form.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka Medical Center
Beersheba
Asher Tal, Prof., +972524600554, astal2001@gmail.com
About this study
Official title: Official Title Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined
The objective of this study is to collect heart rate, respiration data and motion data of patients admitted to sleep lab and to determine the current accuracy level of the EarlySense system vs. the standard system, and predicate device for EarlySense (Embla) used in sleep lab in monitoring heart rate and respiration rates monitors (ECG, respiratory belts, oximeter) that are currently used in the sleep lab among different population (Obese, patients with or without apnea, patients with or without arrhythmia). It is emphasized that no interpretations or clinical decisions will be made based on data received from the ES study device.
Read the detailed description
The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored
- Conditions
- Over Weight, Sleep Disorders
- Medical subject headings
- Sleep Wake Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the detection rate and the accuracy of the EarlySense system in measuring HR and RR and motion as well as capability of system to detect patient turns, bed-exit and entries
Determine the detection rate and the accuracy of the EarlySense system in measuring HR and RR and motion as well as capability of system to detect patient turns, bed-exit and entries
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Over WeightStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EarlySense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asher Tal, Prof., Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036996
- Sponsor's protocol ID
- ES-CLC-2013_Prot_4
- Status last verified
- Jan 2018
- First submitted
- 13 Jan 2014
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Official Title Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined
- ClinicalTrials.gov ID
- NCT02036996
- Acronym / sponsor ID
- ES-CLC-2013_Prot_4
- Conditions
- Over Weight, Sleep Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- EarlySense Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 Jan 2014 (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.
The objective of this study is to collect heart rate, respiration data and motion data of patients admitted to sleep lab and to determine the current accuracy level of the EarlySense system vs. the standard system, and predicate device for EarlySense (Embla) used in sleep lab in monitoring heart rate and respiration rates monitors (ECG, respiratory belts, oximeter) that are currently used in the sleep lab among different population (Obese, patients with or without apnea, patients with or without arrhythmia). It is emphasized that no interpretations or clinical decisions will be made based on data received from the ES study device.
Detailed description
The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Different patient population will be monitored including obese, morbidly obese, patients with or without apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored
Key inclusion criteria (1 listed)
- 1. Age 18 years or more 2. Is willing to sign the consent form.
Key exclusion criteria (2 listed)
- Age < 18 years
- Is not willing to sign the consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the detection rate and the accuracy of the EarlySense system in measuring HR and RR and motion as well as capability of system to detect patient turns, bed-exit and entries
Time frame: one year
Determine the detection rate and the accuracy of the EarlySense system in measuring HR and RR and motion as well as capability of system to detect patient turns, bed-exit and entries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
Related trials for Over Weight
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruitingPhase 2/3
Infarct Growth After Intravenous Tocilizumab in Adults With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy - ILLUMINATE
Acute Ischemic Stroke
Active, not recruiting
Sustainable Exercise and Nutrition Programs for Managing Metabolic Disorders in Older Women
Metabolic Syndrome, Aging
Not yet recruitingPhase 4
TRPTI Metabolic and GLP-1 Pharmacodynamic Study
Overweight , Obesity
Recruiting
Prebiotic Inulin for Late-Reproductive Individuals
Obesity & Overweight, Perimenopausal Women
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.
Asher Tal, Prof. principal investigator
Soroka University Medical Center
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 Over Weight and Sleep Disorders, 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the detection rate and the accuracy of the EarlySense system in measuring HR and RR and motion as well as capability of system to detect patient turns, bed-exit and entries (time frame: one year). It is what the study was designed to measure, not a finding.
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 1 Feb 2018.