An observational study in Activity, Motor, Sleep and Delirium, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-10-03.
Sponsored by University of Texas Southwestern Medical Center · Observational
Among 262 studies in Delirium with a site in United States — 37 open to participants now, 59 under way, 7 of them phase 3. Delirium · United States.
Among the 262 studies in Delirium with a site in United States, this one is the 42nd largest by enrollment of the 69 observational ones that give a count, is one of 20 that started in 2017, is one of 69 observational ones, and was the 133rd registered.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
Browse Delirium studies →37 of the 262 studies in Delirium with a site in United States are open now. Recruiting first, the newest first:
The Methodist Hospital Research Institute · Sites in United States
Northwestern University · Sites in United States
Ceribell Inc. · Sites in United States
Washington University School of Medicine · Sites in United States
Indiana University · Sites in United States
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 127 Delirium studies recruiting now, 99 (78%) set no upper age limit and 8 (6%) stop at 75 or younger; 8 take children under 18; 15 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
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262 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 8 · Phase 2 32 · Phase 3 25 · Phase 4 32
First in 2000; this study’s year is marked. 20 started in 2017.
This study's enrollment of 91 is below the median of 194 across 342 observational studies indexed under Delirium.
Median enrollment 87 across the 193 interventional studies, 124 across the 69 observational. Of the 171 that completed or were terminated, 67 (39%) have results posted.
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12 of 262 have an industry lead sponsor. The 10 most frequent:
University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
University of Texas Southwestern Medical Center has 3 studies filed under Delirium — fewer than ten, so there is no comparison to draw.
21 of the studies in Delirium with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05431595Phase 3M.D. Anderson Cancer CenterManaging Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy | 2027-02-02 |
| NCT06969287Phase 3Washington University School of MedicineMitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery | 2027-04-01 |
| NCT06192615Phase 3Massachusetts General HospitalMinimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II) | 2027-10-31 |
| NCT03182335University of ChicagoVasopressor SAT Study | 2026-11 |
| NCT05127265University of FloridaPervasive Sensing and AI in Intelligent ICU | 2026-12 |
Among the 262 studies in Delirium with a site in United States, from their registry updates:
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Wireless wearable devices (WWD) have been shown to be an effective means to measure patient activity and sleep-wake cycles in the ICU. However, no current studies involving WWD have demonstrated the ability of these devices to measure adverse outcomes, including delirium in critically ill patients. This study is unique because the investigators will implement monitoring with the WWD prior to extubation in the ICU to correctly measure first mobilization, as well as capture quality of sleep and episodes of delirium for the first five postoperative days.
In this single-center non-randomized prospective cohort study, cardiac surgical patients undergoing cardiac surgery with cardiopulmonary bypass will be enrolled consecutively with written informed consent from the time this protocol is approved by the IRB until 100 subjects are enrolled (expected duration of subject enrollment is 12 months). Upon arrival into the ICU, cardiac surgery subjects will have a Fitbit Charge 2 device placed on their wrist and will wear the device until the fifth post-operative day. This device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear. No identifiable patient information will be entered into the smartphone application or transmitted to any external entity.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's enrollment of 91 is below the median of 194 across 342 observational studies indexed under Delirium.
Browse Delirium studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Compared within Delirium, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery at UT Southwestern Medical Center.
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:
Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass.
Device: Wireless Wearable Device
Wireless Wearable Device will be placed on the wrist of the patient prior to extubation in the ICU to record patient activity in terms of steps and sleep quality.
Number of steps walked
Number of steps walked as measured by the Wireless Wearable Device
Time frame: Postoperative day 2 to Postoperative day 5
Length of sleep
Number of hours slept with little activity as measured by the Wireless Wearable Device
Time frame: Postoperative Day 1
Delirium
Occurrence of delirium with few hours slept as measured by the Wireless Wearable Device
Time frame: Postoperative Day 2 (after extubation)
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2017 to primary completion in Aug 2019, 28 months.
Of 176 non-industry observational studies under Delirium, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's 28 months is above that.
Counting every sponsor, half of 178 studies reached it within 20 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center →