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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Paula Watson, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00826553
First received: January 20, 2009
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention
Delirium
Respiratory Failure
Drug: Dexmedetomidine
Drug: GABA agonist

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Time spent in standard sleep stages (N1, N2, N3, REM). [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time spent in atypical sleep. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Presence of burst suppression. [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826553

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

No publications provided

Responsible Party: Paula Watson, Assistant Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00826553     History of Changes
Other Study ID Numbers: 081170
Study First Received: January 20, 2009
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
sedative
GABA
alpha 2 agonist
propofol
midazolam
lorazepam
dexmedetomidine
sleep
electroencephalogram
polysomnogram
ICU

Additional relevant MeSH terms:
Delirium
Respiratory Insufficiency
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Midazolam
Lorazepam
Hypnotics and Sedatives
Propofol
Dexmedetomidine
GABA Agonists
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators

ClinicalTrials.gov processed this record on July 26, 2014