Sleep DeprivationNCT03322371
Validation of Frontal EEG to Formal Polysomnography in the ICU
A study testing 2-lead limited electroencephalography recording in people with Sleep Deprivation and Sleep, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Sleep
- What is being tested?
- 2-lead limited electroencephalography recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Scheduled for a standard of care polysomnography lasting at least 8 hours for any condition
- Age 18 or older
- Anticipated to stay in intensive care unit overnight (minimum 8 hours)
- Glasgow Coma Scale score of 13 or great
- Age 18 or older
- Anticipated to stay in the intensive care unit overnight (minimum 8 hours)
- Intubated, sedated, and ventilated
Who cannot join
- Patient/Legally Authorized Representative declines consent
- Group 2: ICU patient, not sedated, not ventilated
- 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
- Presence of traumatic brain injury
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Frontal Limited Lead Electroencephalography (EEG) to Formal Polysomnography (PSG) in the Intensive Care Unit (ICU)
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.
Read the 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.
- Conditions
- Sleep Deprivation, Sleep
- Being tested
- 2-lead limited electroencephalography recording
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-lead limited electroencephalography recordingDevice
Also called Health Subjects in Sleep Lab, ICU patients, not sedated or ventilated, ICU patient, sedated and ventilated
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: 2-lead limited electroencephalography recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Overnight (with a minimum of 960 epochs)
Secondary outcomes (1)
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)
Measured: Overnight (with a minimum of 960 epochs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start6 Nov 2017
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Why it stopped: Difficulty analyzing PSG data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Epitel, Inc.
- Responsible party
- Principal investigator, Joseph Tonna, University of Utah
- Investigators
- Joseph Tonna, MD, FAAEM, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322371
- Sponsor's protocol ID
- 87693
- Status last verified
- Jun 2021
- First submitted
- 23 Oct 2017
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Frontal Limited Lead Electroencephalography (EEG) to Formal Polysomnography (PSG) in the Intensive Care Unit (ICU)
- ClinicalTrials.gov ID
- NCT03322371
- Acronym / sponsor ID
- 87693
- Conditions
- Sleep Deprivation, Sleep
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty analyzing PSG data
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Epitel, Inc.
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health Subjects in Sleep Lab | Other | Device: 2-lead limited electroencephalography recordingAdult 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 |
| ICU patients, not sedated or ventilated | Other | Device: 2-lead limited electroencephalography recordingAdult 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 |
| ICU patients, sedated and ventilated | Other | Device: 2-lead limited electroencephalography recordingAdult 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 or older
- Scheduled for a standard of care polysomnography lasting at least 8 hours for any condition
- Age 18 or older
- Anticipated to stay in intensive care unit overnight (minimum 8 hours)
- Glasgow Coma Scale score of 13 or great
Key exclusion criteria (13 listed)
- Patient/Legally Authorized Representative declines consent
- Group 2: ICU patient, not sedated, not ventilated
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-lead limited electroencephalography recordingAlso: Health Subjects in Sleep Lab, ICU patients, not sedated or ventilated, ICU patient, sedated and ventilatedThe 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. | Device | Health Subjects in Sleep Lab, ICU patients, not sedated or ventilated, ICU patients, sedated and ventilated |
Primary outcome
Sleep Stage Correlation
Time frame: Overnight (with a minimum of 960 epochs)
The correlation of each sleep stage (Wake, NREM1, NREM2, NREM3, REM) as assessed by polysomnography vs. EEG via analysis of 30-second intervals (epochs)
1 secondary outcome
Sleep vs Wake Correlation
Time frame: Overnight (with a minimum of 960 epochs)
Results and safety
The study was stopped early (reason given: Difficulty analyzing PSG data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Tonna, MD, FAAEM principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-lead limited electroencephalography recording in people with Sleep Deprivation and Sleep, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty analyzing PSG data). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Stage Correlation (time frame: Overnight (with a minimum of 960 epochs)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.