Trials / Unknown
UnknownNCT02036996
Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- EarlySense Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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. 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
Conditions
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2014-01-15
- Last updated
- 2018-02-01
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT02036996. Inclusion in this directory is not an endorsement.