Eval EarlySense Bet Lowenstein Sleeplab

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01978340
• Other study ID #: ES-CLC-2013_Prot_1
• Status: Withdrawn
• Phase: N/A
• First received: June 24, 2013
• Last updated: July 17, 2016
• Start date: November 2013
• Est. completion date: April 2014

Study information

• Verified date: December 2015
• Source: EarlySense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Central Apnea
• Obese
• Parasomnias
• Poor Quality Sleep
• Sleep Apnea, Central
• Sleep Apnea, Obstructive
• Sleep Disorders
• Sleep Wake Disorders

Locations

Country	Name	City	State
Israel	Beit Lowenstien	Raa'nana

Sponsors (1)

Lead Sponsor	Collaborator
EarlySense Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab	the measurements from the EarlySense System will be compared with the "Gold standard" equipment that is being used in the sleep Lab	up to 12 hours	No