An interventional study of 2-lead limited electroencephalography recording in Sleep Deprivation and Sleep, sponsored by University of Utah. Terminated at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-08.
Sponsored by University of Utah · Not applicable, Interventional, and Diagnostic
Among 146 studies in Sleep Deprivation with a site in United States — 30 open to participants now, 35 under way, none of them phase 3. Sleep Deprivation · United States.
Among the 146 studies in Sleep Deprivation with a site in United States, this one is the 71st largest by enrollment of the 127 interventional ones that give a count, is one of 9 that started in 2017, is one of 104 with no phase, and was the 64th registered.
314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.
Browse Sleep Deprivation studies →30 of the 146 studies in Sleep Deprivation with a site in United States are open now. Recruiting first, the newest first:
Harmony Biosciences Management, Inc. · Sites in United States
Ages 18–55 · Healthy volunteers
University of Pennsylvania · Sites in United States
Ages 21–60 · Healthy volunteers
University of Arizona · Sites in United States
Ages 18–55
Children's Hospital of Philadelphia · Sites in United States
Ages 13–18
University of Utah · Sites in United States
Ages 18–35 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 43 Sleep Deprivation studies recruiting now, 11 (26%) set no upper age limit and 28 (65%) stop at 75 or younger; 5 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
146 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 9 · Phase 3 1 · Phase 4 7
First in 1999; this study’s year is marked. 9 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 44 is below the median of 50 across 259 interventional studies indexed under Sleep Deprivation.
Median enrollment 56 across the 127 interventional studies, 64 across the 19 observational. Of the 106 that completed or were terminated, 27 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 146 have an industry lead sponsor. The 10 most frequent:
University of Utah is the lead sponsor of 996 studies on the registry; 177 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
University of Utah has 5 studies filed under Sleep Deprivation — fewer than ten, so there is no comparison to draw.
7 of the studies in Sleep Deprivation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06642246Children's Hospital of PhiladelphiaSleep Promotion and Pediatric Hypertension | 2026-11 |
| NCT06336525Brigham and Women's HospitalAdult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities. | 2027-01-31 |
| NCT05393830Beth Israel Deaconess Medical CenterThe Effect of Sleep Loss on Emotion Regulation | 2027-04-01 |
| NCT05703347Children's Hospital of PhiladelphiaOptimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children | 2027-06 |
| NCT02945501U.S. Army Medical Research and Development CommandTranscranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency During NREM Sleep | 2027-06 |
Add all 7 to your calendar (.ics) → With an account.
Among the 146 studies in Sleep Deprivation with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Group 1: Healthy Subjects in Sleep Lab:
Inclusion Criteria
Exclusion Criteria
Group 2: ICU patient, not sedated, not ventilated
Inclusion Criteria
Exclusion Criteria:
Group 3: ICU patient, sedated and ventilated
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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)
Time frame: Overnight (with a minimum of 960 epochs)
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)
Time frame: Overnight (with a minimum of 960 epochs)
Sound and Light during Sleep
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)
Environmental Conditions during Sleep
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)
Ran from Nov 2017 to primary completion in Jan 2020, 25 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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