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NCT01342328 · ClinicalTrials.gov registry record · Phase 1
Providing "Good Sleep" for ICU Sedation
A Phase 1 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01342328: Clinical Trial Phase 1 study, sponsored by University of California, San Francisco.
NCT01342328 is a Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01342328, a Phase 1 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Cognitive dysfunction, either alone or as an element in the syndrome of delirium, is a common occurrence with an incidence as high as 75% in intensive care unit (ICU) patients and can independently result in serious consequences including higher mortality rate. Delirium develops through a complex interaction between the patient's baseline vulnerability (risk factors) and precipitating factors such as disruption of sleep that may occur during hospitalization. While sedative-hypnotic agents that are used to facilitate hypnosis and the management of mechanically ventilated patients converge on the neural substrate that mediate endogenous sleep, they do so at different juncture points depending on its molecular mechanism of hypnotic action. Hypnotic agents that modulate the GABAA receptor converge at the level of the hypothalamus while α2 adrenergic agonists converge on sleep pathways within the brainstem. This translational project seeks to determine whether sedation mediated by activation of α2 adrenoceptors (dexmedetomidine) is more like natural sleep than that provided by a sedative agent that modulates the GABAA receptor (propofol). The investigators will examine volunteers who will be monitored continuously by electroencephalography (EEG) and whole-brain functional connectivity by magnetoencephalography (MEG) during each of three sleep stages, namely, that induced by dexmedetomidine, propofol, or saline (natural sleep, control). The two drug-induced sleep regimens will be compared to natural sleep using EEG and brain connectivity by MEG
Primary Outcome
The investigators will evaluate the "power" in the delta rhythm range and amount of slow-wave-sleep
Interventions
- DRUG Dexmedetomidine
- DRUG Propofol
- OTHER Normal saline infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-11-01 |
| Phase | Phase 1 |
Why NCT01342328 stopped before completion
NCT01342328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexmedetomidine is the first listed.
NCT01342328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01342328 about?
NCT01342328 is a clinical study titled "Providing "Good Sleep" for ICU Sedation". Cognitive dysfunction, either alone or as an element in the syndrome of delirium, is a common occurrence with an incidence as high as 75% in intensive care unit (ICU) patients and can independently result in serious consequences including higher mortality rate. Delirium develops through a complex in...
What is the current status of trial NCT01342328?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2012-05. Estimated completion is 2012-11-01.
What interventions are being tested in trial NCT01342328?
The interventions under investigation include: Dexmedetomidine (DRUG), Propofol (DRUG), Normal saline infusion (OTHER).
Who is sponsoring clinical trial NCT01342328?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01342328's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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