Back to results

Validation of Frontal EEG to Formal Polysomnography in the ICU

Primary Purpose

Sleep Deprivation, Sleep

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

2-lead limited electroencephalography recording

About this trial

This is an interventional diagnostic trial for Sleep Deprivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Group 1: Healthy Subjects in Sleep Lab:

Inclusion Criteria

Age 18 or older
Scheduled for a standard of care polysomnography lasting at least 8 hours for any condition

Exclusion Criteria

Patient/Legally Authorized Representative declines consent

Group 2: ICU patient, not sedated, not ventilated

Inclusion Criteria

Age 18 or older
Anticipated to stay in intensive care unit overnight (minimum 8 hours)
Glasgow Coma Scale score of 13 or great

Exclusion Criteria:

Intubated with endotracheal tube
Sedated (includes sedative drugs such as propofol, Dexmedetomidine, versed infusion above 2mg/hr, ketamine infusion above 0.2 mg/kg/hr).

Group 3: ICU patient, sedated and ventilated

Inclusion Criteria:

Age 18 or older
Anticipated to stay in the intensive care unit overnight (minimum 8 hours)
Intubated, sedated, and ventilated

Exclusion Criteria:

Presence of traumatic brain injury
Planned extubation in next 8 hours
Scheduled to leave the intensive care unit for any reason in the next 8 hours
Anticipated life expectancy of less than 24 hours
Electroencephalogram monitoring (current or scheduled in the next 8 hours)
Hemodynamic instability (defined as: (i) mean arterial pressure <60mmHg for >20 minutes with efforts to raise it or (ii) >2 liter fluid administered in 2h after operating room and anticipating on-going needs for fluid resuscitation or (iii) ICU MD determination of "atypical and profound hemodynamic instability" or (iv) PI determination after evaluation.
Refractory hypoxemia - defined as Saturation <88% on Sp02 despite efforts to increase it
Hemorrhage - defined as >500cc chest tube output in 2h and anticipated need of more than 2 units of packed red blood cells in immediate post op period. This does NOT include cell-saver.

Sites / Locations

University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Health Subjects in Sleep Lab

ICU patients, not sedated or ventilated

ICU patients, sedated and ventilated

Arm Description

Adult patients (> 18yrs old) scheduled for a standard of care PSG (sleep study) lasting at least 8 hours for any condition. Patients will undergo simultaneous 2-lead limited EEG recording with experimental device. 2-lead limited electroencephalography recording

Adult ICU patients (> 18yrs old) anticipated to stay in the ICU overnight (minimum 8 hours) with a Glasgow Coma Scale of 13 or greater, not intubated and not sedated. Patients will undergo simultaneous 2-lead limited electroencephalography recording

Adult ICU patients (> 18yrs old) who are intubated, sedated, ventilated, and anticipated to stay in the ICU overnight (minimum 8 hours). Patients will undergo simultaneous 2-lead limited electroencephalography recording

Outcomes

Primary Outcome Measures

Sleep Stage Correlation

The correlation of each sleep stage (Wake, NREM1, NREM2, NREM3, REM) as assessed by polysomnography vs. EEG via analysis of 30-second intervals (epochs)

Secondary Outcome Measures

Sleep vs Wake Correlation

The correlation of sleep (NREM1, NREM2, NREM3, REM) vs wake as assessed by polysomnography vs. EEG via analysis of 30-second intervals (epochs)

Full Information

NCT ID

NCT03322371

First Posted

October 23, 2017

Last Updated

June 2, 2021

Sponsor

University of Utah

Collaborators

Epitel, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03322371

Brief Title

Validation of Frontal EEG to Formal Polysomnography in the ICU

Official Title

Validation of Frontal Limited Lead Electroencephalography (EEG) to Formal Polysomnography (PSG) in the Intensive Care Unit (ICU)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Terminated

Why Stopped

Difficulty analyzing PSG data

Study Start Date

November 6, 2017 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

Collaborators

Epitel, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare a 2-lead frontal electroencephalogram recording to a formal polysomnography (PSG) in detecting sleep vs. wake and depth of sleep in both healthy and ICU patients.

Detailed Description

Sleep in the intensive care unit (ICU) is poor and not well understood. Formal polysomnography (PSG) is the gold standard measure, but impractical for critical care. The relative influence of environment, illness and interventions on sleep in critically ill patients is therefore essentially unknown. Interventions to improve sleep have been pragmatic and outcomes subjective or indirect, and uninformed. When it is done, formal PSG in critical illness demonstrates fragmented, shortened, interrupted and non-circadian sleep, with environmental noise, light, and frequent physical stimulation causing arousals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Deprivation, Sleep

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Health Subjects in Sleep Lab

Arm Type

Other

Arm Description

Arm Title

ICU patients, not sedated or ventilated

Arm Type

Other

Arm Description

Arm Title

ICU patients, sedated and ventilated

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

2-lead limited electroencephalography recording

Other Intervention Name(s)

Health Subjects in Sleep Lab, ICU patients, not sedated or ventilated, ICU patient, sedated and ventilated

Intervention Description

The EEG recording device will be placed in conjunction with the standard formal polysomnography (PSG). The EEG device will remain in place as long as PSG leads are connected to the subject and PSG machine.

Primary Outcome Measure Information:

Title

Sleep Stage Correlation

Description

The correlation of each sleep stage (Wake, NREM1, NREM2, NREM3, REM) as assessed by polysomnography vs. EEG via analysis of 30-second intervals (epochs)

Time Frame

Overnight (with a minimum of 960 epochs)

Secondary Outcome Measure Information:

Title

Sleep vs Wake Correlation

Description

The correlation of sleep (NREM1, NREM2, NREM3, REM) vs wake as assessed by polysomnography vs. EEG via analysis of 30-second intervals (epochs)

Time Frame

Overnight (with a minimum of 960 epochs)

Other Pre-specified Outcome Measures:

Title

Sound and Light during Sleep

Description

The correlation of sleep stage (Wake, NREM1, NREM2, NREM3, REM) with sound and light levels within the ICU.

Time Frame

Overnight (with a minimum of 960 epochs)

Title

Environmental Conditions during Sleep

Description

The correlation of sleep stage (Wake, NREM1, NREM2, NREM3, REM) with environmental conditions within the ICU.

Time Frame

Overnight (with a minimum of 960 epochs)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Group 1: Healthy Subjects in Sleep Lab: Inclusion Criteria Age 18 or older Scheduled for a standard of care polysomnography lasting at least 8 hours for any condition Exclusion Criteria Patient/Legally Authorized Representative declines consent Group 2: ICU patient, not sedated, not ventilated Inclusion Criteria Age 18 or older Anticipated to stay in intensive care unit overnight (minimum 8 hours) Glasgow Coma Scale score of 13 or great Exclusion Criteria: Intubated with endotracheal tube Sedated (includes sedative drugs such as propofol, Dexmedetomidine, versed infusion above 2mg/hr, ketamine infusion above 0.2 mg/kg/hr). Group 3: ICU patient, sedated and ventilated Inclusion Criteria: Age 18 or older Anticipated to stay in the intensive care unit overnight (minimum 8 hours) Intubated, sedated, and ventilated Exclusion Criteria: Presence of traumatic brain injury Planned extubation in next 8 hours Scheduled to leave the intensive care unit for any reason in the next 8 hours Anticipated life expectancy of less than 24 hours Electroencephalogram monitoring (current or scheduled in the next 8 hours) Hemodynamic instability (defined as: (i) mean arterial pressure <60mmHg for >20 minutes with efforts to raise it or (ii) >2 liter fluid administered in 2h after operating room and anticipating on-going needs for fluid resuscitation or (iii) ICU MD determination of "atypical and profound hemodynamic instability" or (iv) PI determination after evaluation. Refractory hypoxemia - defined as Saturation <88% on Sp02 despite efforts to increase it Hemorrhage - defined as >500cc chest tube output in 2h and anticipated need of more than 2 units of packed red blood cells in immediate post op period. This does NOT include cell-saver.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Tonna, MD, FAAEM

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Validation of Frontal EEG to Formal Polysomnography in the ICU

We'll reach out to this number within 24 hrs