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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826553
Recruitment Status : Terminated (poor recruitment)
First Posted : January 22, 2009
Last Update Posted : June 5, 2017
Information provided by (Responsible Party):
Wes Ely, Vanderbilt University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Delirium Respiratory Failure Drug: Dexmedetomidine Drug: GABA agonist Phase 1

Detailed Description:
This is a single center randomized pilot study comparing the effects of an α2 agonist (dexmedetomidine) versus GABA agonists (propofol or a benzodiazepine) on total sleep time and sleep quality. For the purposes of enrollment and analysis all benzodiazepines used for sedation (mainly midazolam and lorazepam) will be considered equivalent. Patients who are mechanically ventilated and sedated will be enrolled. The initial sedative will be determined by the managing medical team and the medication will be active at the time of enrollment. The patients will then be randomized to either continue their current sedative or be switched to either propofol or dexmedetomidine. PSG data will be collected for up to 96 hours, beginning at enrollment for all patients. The analysis of PSG will not begin until after a 8 hour "washout" period has completed to minimize carryover effect of prior sedatives.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists
Study Start Date : January 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: GABA agonist Drug: GABA agonist
Patients sedated with GABA agonists (e.g. propofol, benzodiazepines) during mechanical ventilation will be enrolled. Patients randomized to the GABA agonist arm will continue the sedative that is active at enrollment. The specific drug as well as dosage, frequency, and duration will be determined and titrated by the managing clinical team.
Other Names:
  • Typical GABA agonists include:
  • 1) propofol
  • 2) midazolam
  • 3) lorazepam.

Experimental: Alpha 2 agonist Drug: Dexmedetomidine
Standard of care sedative. Dosage, frequency, and duration will be determined by the managing clinical team.

Primary Outcome Measures :
  1. Time spent in standard sleep stages (N1, N2, N3, REM). [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. Time spent in atypical sleep. [ Time Frame: 4 days ]
  2. Presence of burst suppression. [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00826553

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Principal Investigator: Paula L Watson, MD Vanderbilt School of Medicine

Responsible Party: Wes Ely, Professor, Vanderbilt University Medical Center Identifier: NCT00826553     History of Changes
Other Study ID Numbers: 081170
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017

Keywords provided by Wes Ely, Vanderbilt University Medical Center:
alpha 2 agonist

Additional relevant MeSH terms:
Respiratory Insufficiency
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Hypnotics and Sedatives
gamma-Aminobutyric Acid
GABA Agonists
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists