An interventional study of Earplugs and eye masks in Delirium and Hospital Acquired Condition, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-05.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
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 160th largest by enrollment of the 193 interventional ones that give a count, is one of 16 that started in 2018, is one of 104 with no phase, and was the 149th 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
Ages up to 65
Northwestern University · Sites in United States
Ages 18+
Ceribell Inc. · Sites in United States
Ages 18+
Washington University School of Medicine · Sites in United States
Ages 60+
Indiana University · Sites in United States
Ages 50+
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: 65 Years and older · all sexes · healthy volunteers too.
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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. 16 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 112 across 550 interventional 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:
Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Duke University has 6 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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There has been some recent evidence to support the use of earplugs and eye masks to prevent delirium, but the existing studies have been small, have not been thoroughly replicated, and have only been conducted with intensive care unit (ICU) patients. Therefore, we propose to conduct a single-arm pilot study for an eventual single-blinded randomized controlled trial designed to assess the efficacy of earplugs and eye masks worn at night for prevention of delirium in a population of general medicine inpatients over the age of 65. The primary outcome will be incidence of delirium as measured by Confusion Assessment Method (CAM). In this pilot study, we will assess feasibility and will not perform any statistical comparisons. In the subsequent randomized controlled trial, we will be comparing the hazard rates on an intention-to-treat basis. Secondary outcomes will be exploratory and include length of stay, cost data, and use of pharmacologic interventions for sleep, delirium, or agitation. There are no physical risks and no cost to the subjects in this study.
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:
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Earplugs and eye masks
Patients in this study will be given earplugs and eye masks to be worn during sleep
Incidence of delirium
Will be assessed using the CAM
Time frame: The first 5 days of patients' hospitalization
Feasibility as measured by number of patients screened
Time frame: 5 days
Feasibility as measured by number of patients ineligible
Time frame: 5 days
Feasibility as measured by number of patients who decline to participate
Time frame: 5 days
Feasibility as measured by number of patients who dropped out of the study
Time frame: 5 days
Feasibility as measured by number of patients who wore the earplugs
Time frame: 5 days
Feasibility as measured by number of patients who wore the eye masks
Time frame: 5 days
Feasibility as measured by number of CAM assessment days
Time frame: 5 days
Feasibility as measured by number of patients who successfully completed the study
Time frame: 5 days
Ran from Aug 2018 to primary completion in Dec 2018, 4 months.
Of 219 non-industry interventional studies with no phase under Delirium, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's 4 months is below that.
Counting every sponsor, half of 222 studies reached it within 26 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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