DeliriumPhase 1HYPNOSNCT00826553
How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units
A Phase 1 study testing Dexmedetomidine and GABA agonist in people with Delirium and Respiratory Failure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Respiratory Failure
- What is being tested?
- Dexmedetomidine and GABA agonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists
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.
Read the 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.
- Conditions
- Delirium, Respiratory Failure
- Being tested
- Dexmedetomidine, GABA agonist
- Keywords
- sedative, GABA, alpha 2 agonist, propofol, midazolam, lorazepam, dexmedetomidine, sleep, electroencephalogram, polysomnogram, ICU
- Medical subject headings
- Delirium, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Standard of care sedative. Dosage, frequency, and duration will be determined by the managing clinical team.
GABA agonistDrug
Also called Typical GABA agonists include:, 1) propofol, 2) midazolam, 3) lorazepam.
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.
| Study group | Role | What they receive |
|---|---|---|
| GABA agonist | Experimental | Not described Receives: Drug: GABA agonist |
| Alpha 2 agonist | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in standard sleep stages (N1, N2, N3, REM).
Measured: 4 days
Secondary outcomes (2)
Time spent in atypical sleep.
Measured: 4 days
Presence of burst suppression.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wes Ely, Vanderbilt University Medical Center
- Investigators
- Paula L Watson, MD, Principal investigator, Vanderbilt School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826553
- Sponsor's protocol ID
- 081170
- Acronym
- HYPNOS
- Status last verified
- Jun 2017
- First submitted
- 20 Jan 2009
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists
- ClinicalTrials.gov ID
- NCT00826553
- Acronym / sponsor ID
- HYPNOS / 081170
- Conditions
- Delirium, Respiratory Failure
- Keywords
- sedative, GABA, alpha 2 agonist, propofol, midazolam, lorazepam, dexmedetomidine, sleep
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GABA agonist | Experimental | Drug: GABA agonist |
| Alpha 2 agonist | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineStandard of care sedative. Dosage, frequency, and duration will be determined by the managing clinical team. | Drug | Alpha 2 agonist |
| GABA agonistAlso: Typical GABA agonists include:, 1) propofol, 2) midazolam, 3) lorazepam.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. | Drug | GABA agonist |
Primary outcome
Time spent in standard sleep stages (N1, N2, N3, REM).
Time frame: 4 days
2 secondary outcomes
Time spent in atypical sleep.
Time frame: 4 days
Presence of burst suppression.
Time frame: 4 days
Results and safety
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
Related trials for Delirium
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
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Dementia, Postoperative Delirium (POD)
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula L Watson, MD principal investigator
Vanderbilt School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine and GABA agonist in people with Delirium and Respiratory Failure, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent in standard sleep stages (N1, N2, N3, REM). (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.