Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined

NCT ID: NCT02036996

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-12-31

Brief 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

Over Weight; Sleep Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Age < 18 years
• Is not willing to sign the consent form.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EarlySense Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asher Tal, Prof.

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

Soroka Medical Center

Beersheba, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Asher Tal, Prof.

Role: primary

astal2001@gmail.com

+972524600554

Other Identifiers

ES-CLC-2013_Prot_4

Identifier Type: -

Identifier Source: org_study_id