An observational study in Sleep Deprivation and Delirium, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by University of Utah · Observational
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 3rd largest by enrollment of the 19 observational ones that give a count, is one of 9 that started in 2017, is one of 19 observational ones, and was the 63rd 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 · all sexes · no healthy volunteers.
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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 685 is above the median of 53 across 52 observational 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.
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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 analyze a multi-component sleep/wake protocol for optimization of environmental factors (noise, light, nursing activities) as well as non-environmental factors (pain, mechanical support devices, procedures) to improve quality of sleep and decrease incidence of ICU delirium in the Cardiovascular and Surgical ICU (CVICU/SICU).
Fifty-percent of ICU patient sleep hours occur during the day in short bouts which decreases overall sleep quality. Approximately 47-87% of critically ill patients in the ICU experience an episode of delirium, which can result in changes in cognition, longer hospital stay, and physiologic consequences. Research suggests that both patients and staff members can identify environmental factors, such as noise, light, and nursing activities, as well as non-environmental factors such as mechanical devices, procedures, and medications as contributing factors to lack of sleep. However, both nursing staff and providers may underestimate the intensity of the perceived noise in the ICU. This includes those frequent nighttime interruptions, of environmental and non-environmental origins, which can cause fragmented sleep. Providers and nurses are aware of the factors contributing to sleep deprivation, but they may "lower prioritization of patient sleep [as a] tradeoff [for] current standard of care."
Studies have shown that sleep deprivation in critically ill patients can lead to changes in patient cognition, increased hospital and ICU length of stay, and physiologic consequences. These consequences are influenced from patient clinical status as well as modifiable risk factors. One study identified that barriers to the optimization of sleep include patient disease severity, mechanical ventilation, sedation, noise, light, and nurse-patient interaction. It identified a possible association between lack of sleep and cognition with additional consequences of longer mechanical ventilator time, and cardiovascular, pulmonary, and immune system dysfunctions.
Implementation of a protocol directed at optimizing environmental and non-environmental factors has been shown to improve patients' perceived and actual quality of sleep as well as a reduction in ICU delirium.
Another study studied sleep and delirium in a medical ICU after implementation of sleep-promoting interventions. Interventions aimed at reducing light, noise, nursing interruptions, and sedating medications were applied in a three-part process. Patients were surveyed using the Richards-Campbell Sleep Questionnaire and delirium was measured by delirium/coma-free days. Post-interventions resulted in an increase in delirium/coma-free days and an improvement in the amount of perceived noise.
One research group implemented a similar bundle that was aimed at improvement of sleep and delirium in both medical and surgical ICU patients. Their efforts were directed towards reduction in environmental factors as well as avoidance of sedating medications and long mechanical ventilator times. The Richards-Campbell Sleep Questionnaire was used to survey patients on quality of sleep and the Confusion Assessment Method for the ICU was measured daily for incidence of delirium. They found that patients' perceived quality of sleep increased with decreased daytime sleepiness as well as reductions in noise, light, and nursing interventions. Furthermore, they found that implementation of this bundle led to a decrease in length of delirium.
Study participants will be drawn from those admitted into the Cardiovascular or Surgical Intensive Care Units at the University of Utah University Hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No implementation of the sleep/wake protocol. A subset of participants in this group will have light and sound levels in the room recorded.
The sleep/wake protocol will be implemented. A subset of participants in this group will also have light and sound levels in the room recorded.
Behavioral: Sleep/Wake Protocol
Day RN observes if completed per pt: no caffeine after 3 pm, encourage activities to prevent napping (chart % day spent napping), Lights on blinds/door open, Reasonable effort for some noise in room, Eye glasses hearing aids applied, Chair position/mobility at least 2x30 minutes. Night RN observe if completed per pt: Appropriate pain control, Optimize room temp, Warm bath before 2200, TV off by 2200, Prevent extra alarms after 2200, Close room curtain by 2200, Dim room lights by 2200, Family out by 2200, Door half/fully closed after 2200, # RN interruptions after 2200, Offer eye mask/ear plugs, Meds administered for sleep (dilaudid, fentanyl oxycodone, haldol, quetiapine, propofol, melatonin, or other), Dim hallway lights by 2200, Nurses station quiet
Incidence of ICU delirium
Participants will be evaluated for delirium using the Confusion Assessment Method for the ICU (CAM-ICU)
Time frame: Two times daily until ICU discharge (up to 4 months)
Ran from Oct 2017 to primary completion in Mar 2018, 5 months.
Of 25 observational studies under Sleep Deprivation, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 58. This study's 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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