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

Primary Purpose

Delirium, Respiratory Failure

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
GABA agonist
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Delirium focused on measuring sedative, GABA, alpha 2 agonist, propofol, midazolam, lorazepam, dexmedetomidine, sleep, electroencephalogram, polysomnogram, ICU

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GABA agonist

Alpha 2 agonist

Arm Description

Outcomes

Primary Outcome Measures

Time spent in standard sleep stages (N1, N2, N3, REM).

Secondary Outcome Measures

Time spent in atypical sleep.
Presence of burst suppression.

Full Information

First Posted
January 20, 2009
Last Updated
June 1, 2017
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00826553
Brief Title
How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units
Acronym
HYPNOS
Official Title
Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Respiratory Failure
Keywords
sedative, GABA, alpha 2 agonist, propofol, midazolam, lorazepam, dexmedetomidine, sleep, electroencephalogram, polysomnogram, ICU

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GABA agonist
Arm Type
Experimental
Arm Title
Alpha 2 agonist
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Standard of care sedative. Dosage, frequency, and duration will be determined by the managing clinical team.
Intervention Type
Drug
Intervention Name(s)
GABA agonist
Other Intervention Name(s)
Typical GABA agonists include:, 1) propofol, 2) midazolam, 3) lorazepam.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time spent in standard sleep stages (N1, N2, N3, REM).
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Time spent in atypical sleep.
Time Frame
4 days
Title
Presence of burst suppression.
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula L Watson, MD
Organizational Affiliation
Vanderbilt School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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

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