NCT02036996

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

4.9 years

First QC Date

January 13, 2014

Last Update Submit

January 31, 2018

Conditions

Over WeightSleep Disorders

Outcome Measures

Primary Outcomes (1)

  • 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

    one year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Medical Center

Beersheba, Israel

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Asher Tal, Prof.

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 15, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

IL(1)