How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units

Stopped early · Phase 1

Conditions studied: Delirium, Respiratory Failure

In brief

The purpose of this study is to study the effect of two standard of care sedative medications on sleep stages and total sleep time. The investigators hypothesize that the α2 agonist, dexmedetomidine, will improve sleep quality by increasing N2 and N3 sleep as well as total sleep time when compared to GABA agonists.

Key facts

Study ID: NCT00826553
Run by: Vanderbilt University Medical Center
People needed: 6
Starts: 2009-01-01
Expected to finish: 2013-12-01
Last updated by the study team: 2017-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adult patients admitted to the medical intensive care unit who require mechanical ventilation and are sedated with a GABA agonist with the expectation of being mechanically ventilated for greater than 24 hours.

You may not qualify if…

Subjects who are less than 18 years
Subjects who are pregnant (a pregnancy test will be performed on all women of child bearing age)
Inability to obtain informed consent from the patient or his/her surrogate
Subjects who are physiologically benzodiazepine dependent, and at risk of withdrawal syndromes
Subjects with anoxic brain injuries, strokes, or neurotrauma
Medical team following patient unwilling to change sedation regimen
Subjects who are moribund and not expected to survive 24 hours or actively withdrawing medical support
Documented allergy to study medications
Subjects with advanced heart block at time of screening
Prisoners
RASS target of less than or equal to -4 at the time of screening
PSG equipment unavailable

Where it is running

Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.