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Eval EarlySense Bet Lowenstein Sleeplab

Evaluation of EarlySense - a Contact-less Heart and Respiration Rate Monitor in Hospitalized Patients

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01978340
Enrollment
0
Registered
2013-11-07
Start date
2013-11-30
Completion date
2014-04-30
Last updated
2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Apnea, Obese, Poor Quality Sleep, Sleep Apnea, Obstructive, Sleep Disorders

Brief summary

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

Detailed description

EarlySense sensors will be placed under the mattress of subjects who have been included in the study. The sensors will not be in any contact with the patient. Two sensors will be utilized and placed under the subject's chest and pelvis area. Accuracy of the sensors will be compared to each other and to the reference device.

Interventions

None listed

Sponsors

EarlySense Ltd.
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Age 18 years or above 2. Is willing to sign the consent form

Exclusion criteria

1. Age \< 18 years 2. Is not willing to sign the consent form

Design outcomes

Primary

MeasureTime frameDescription
To determine the accuracy level of the EarlySense system vs. the monitors used in sleep labup to 12 hoursthe measurements from the EarlySense System will be compared with the Gold standard equipment that is being used in the sleep Lab

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026