NCT03322371

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

2.2 years

First QC Date

October 23, 2017

Last Update Submit

June 2, 2021

Conditions

Sleep DeprivationSleep

Outcome Measures

Primary Outcomes (1)

  • 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)

    Overnight (with a minimum of 960 epochs)

Secondary Outcomes (1)

  • Sleep vs Wake Correlation

    Overnight (with a minimum of 960 epochs)

Other Outcomes (2)

  • Sound and Light during Sleep

    Overnight (with a minimum of 960 epochs)

  • Environmental Conditions during Sleep

    Overnight (with a minimum of 960 epochs)

Study Arms (3)

Health Subjects in Sleep Lab

OTHER

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

Device: 2-lead limited electroencephalography recording

ICU patients, not sedated or ventilated

OTHER

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

Device: 2-lead limited electroencephalography recording

ICU patients, sedated and ventilated

OTHER

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

Device: 2-lead limited electroencephalography recording

Interventions

2-lead limited electroencephalography recordingDEVICE

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.

Also known as: Health Subjects in Sleep Lab, ICU patients, not sedated or ventilated, ICU patient, sedated and ventilated
Health Subjects in Sleep LabICU patients, not sedated or ventilatedICU patients, sedated and ventilated

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patient/Legally Authorized Representative declines consent
  • Group 2: ICU patient, not sedated, not ventilated
  • Age 18 or older
  • Anticipated to stay in intensive care unit overnight (minimum 8 hours)
  • Glasgow Coma Scale score of 13 or great
  • 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
  • Age 18 or older
  • Anticipated to stay in the intensive care unit overnight (minimum 8 hours)
  • Intubated, sedated, and ventilated
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Joseph Tonna, MD, FAAEM

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, ECMO Services

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 26, 2017

Study Start

November 6, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

June 8, 2021

Record last verified: 2021-06

Locations

US(1)