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NCT04329091 · ClinicalTrials.gov registry record · Phase 4

Implications of Anesthetics on Sleep Consolidation

A Phase 4 study, sponsored by University of Chicago.

Terminated
Registry status
Phase 4
Development phase
9
Enrollment target

NCT04329091: Clinical Trial Phase 4 study, sponsored by University of Chicago.

NCT04329091 is a Phase 4 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 9 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04329091, a Phase 4 study, was terminated before completion, sponsored by University of Chicago.

TERMINATED
Registry status
Phase 4
Development phase
9 participants
Enrollment target

Study Summary

Sleep leads to consolidation of learning in humans, restoring memories that were forgotten over a waking day and protecting memories against future forgetting. Although theories of consolidation have linked sleep spindles seen on electroencephalography to consolidation due to their putative role in hippocampal transfer to the neocortex (Antony et al, 2019; Antony \& Paller, 2017), spindles have not yet been linked to consolidation of perceptual learning or generalized learning. Prior research by a collaborator on this project has shown that sleep specifically aids in the consolidation of generalized perceptual learning of speech (Fenn, Nusbaum, \& Margoliash, 2003). Subjects show a 10-point reduction in performance after a waking retention period, while no loss is found after a retention period containing sleep (Fenn et al., 2003). Various measurable activities in the brain are associated with memory consolidation during sleep. This project intends study the effect of dexmedetomidine on memory consolidation during sleep Hypothesis 1 The gain in perceptual learning after a 90 minute natural sleep nap will also occur after 90 minutes of a sufficient dose of IV dexmedetomidine to replicate sleep. This result would suggest that consolidation can occur under this anesthetic state of consciousness. Hypothesis 2 The number and quality of sleep spindles seen on EEG in subjects administered dexmedetomidine will correlate with this gain in perceptual learning. This result would suggest that biomimetic sleep spindles are sufficient for producing memory consolidation. Only those subjects capable of giving their own consent will be considered for this study. The study will enroll 20 healthy subjects for this study between the ages of 18 and 35. All volunteers will be fit and healthy, meeting the American Society of Anesthesiologists (ASA) physical status classification ASA 1 (normal healthy subjects) and ASA 2 (stable chronic condition) and of normal body habitus. Prior to

Primary Outcome

Subjects are tested in the morning for word recognition on hard-to-understand speech, then trained on this speech (never hearing the same words twice) which produces about 20 percentage points of improvement. After sedation subjects are re-tested. During the morning, afternoon and evening post-tests, subjects will be tested on new spoken words. At each time point where the perceptual learning protocol is administered the number of words correctly perceived out of 50 will be measured.

Interventions

  • DRUG Dexmedetomidine

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2020-10-16
Est. Completion 2021-12-20
Phase Phase 4
University of Chicago

796 total trials

Why NCT04329091 stopped before completion

NCT04329091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Dexmedetomidine is the first listed.

NCT04329091 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04329091 about?

NCT04329091 is a clinical study titled "Implications of Anesthetics on Sleep Consolidation". Sleep leads to consolidation of learning in humans, restoring memories that were forgotten over a waking day and protecting memories against future forgetting. Although theories of consolidation have linked sleep spindles seen on electroencephalography to consolidation due to their putative role in ...

What is the current status of trial NCT04329091?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2020-10-16. Estimated completion is 2021-12-20.

What interventions are being tested in trial NCT04329091?

The interventions under investigation include: Dexmedetomidine (DRUG).

Who is sponsoring clinical trial NCT04329091?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04329091's enrollment target sits among peer trials

9 1968th of 2000 higher than 29 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT04329091, the US trial registry maintained by the National Library of Medicine. NCT04329091 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.