Poor Quality SleepNCT01966315
The Comparison of Dexmedetomidine and Midazolam for the Sleep in Intensive Care Unit
An observational study of Poor Quality Sleep and Sleep Deprivation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography in critically ill patients. And the investigators also compare the incidence of delirium between the two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Poor Quality Sleep, Sleep Deprivation, Sleep Arousal Disorders
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Dec 2016
- Phase
- Observational
- 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
Study population: Critical patients who take a sedative drugs (dexmedetomidine or midazolam).
Who may be able to join
- sedation patients with dexmedetomidine or midazolam
- over 18 years old
Who cannot join
- Neurologic disease (stroke, seizure, dementia, hypoxic brain damage)
- Brain infection
- Alcoholics
- Major Depression Disorder, Schizophrenia, Anxiety disorder
- Hearing loss
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: The Comparison of Dexmedetomidine and Midazolam for the Sleep of Mechanical Ventilated Intensive Care Unit Patients
The investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography in critically ill patients. And the investigators also compare the incidence of delirium between the two groups.
Read the detailed description
Sleep is very important for cognitive and immune function. However, patients in intensive care unit (ICU) have a very poor sleep.
Almost all ventilated patients in intensive care unit (ICU) take a sedative drug. In Korea, most commonly used sedative drugs are dexmedetomidine and midazolam.
The investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography. And the investigators also compare the incidence of delirium between the two groups.
- Medical subject headings
- Sleep Deprivation, Sleep Arousal Disorders, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Dexmedetomidine group is the patients who sedated with dexmedetomidine in intensive care unit. We will randomly allocate using www.randomizer.org. They will sedate at the level of RASS -2. The dose of dexmedetomidine will be 0.2-0.7ug/kg/hr. | |
| Midazolam group | Midazolam group is the patients who sedated with midazolam in intensive care unit. We will randomly allocate using www.randomizer.org. They will sedate at the level of RASS -2. The dose of midazolam will be 0.05-0.1 mg/kg/hr. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences of sleep stage, sleep efficiency, arousal index and delirium between dexmedetomidine group and midazolam group
Measured: during ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2016
- Study completionDec 2016
Why it stopped: The portable PSG machine can not be available any more.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Quality SleepStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young-Jae Cho, MPH, Study chair, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Gyeonggi, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966315
- Sponsor's protocol ID
- B-1307/212-010
- Status last verified
- Dec 2015
- First submitted
- 13 Oct 2013
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Dexmedetomidine and Midazolam for the Sleep of Mechanical Ventilated Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT01966315
- Acronym / sponsor ID
- B-1307/212-010
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The portable PSG machine can not be available any more.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Oct 2013 (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 investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography in critically ill patients. And the investigators also compare the incidence of delirium between the two groups.
Detailed description
Sleep is very important for cognitive and immune function. However, patients in intensive care unit (ICU) have a very poor sleep.
Almost all ventilated patients in intensive care unit (ICU) take a sedative drug. In Korea, most commonly used sedative drugs are dexmedetomidine and midazolam.
The investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography. And the investigators also compare the incidence of delirium between the two groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | – | –Dexmedetomidine group is the patients who sedated with dexmedetomidine in intensive care unit. We will randomly allocate using www.randomizer.org. They will sedate at the level of RASS -2. The dose of dexmedetomidine will be 0.2-0.7ug/kg/hr. |
| Midazolam group | – | –Midazolam group is the patients who sedated with midazolam in intensive care unit. We will randomly allocate using www.randomizer.org. They will sedate at the level of RASS -2. The dose of midazolam will be 0.05-0.1 mg/kg/hr. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical patients who take a sedative drugs (dexmedetomidine or midazolam).
Key inclusion criteria (2 listed)
- sedation patients with dexmedetomidine or midazolam
- over 18 years old
Key exclusion criteria (5 listed)
- Neurologic disease (stroke, seizure, dementia, hypoxic brain damage)
- Brain infection
- Alcoholics
- Major Depression Disorder, Schizophrenia, Anxiety disorder
- Hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The differences of sleep stage, sleep efficiency, arousal index and delirium between dexmedetomidine group and midazolam group
Time frame: during ICU stay
Results and safety
The study was stopped early (reason given: The portable PSG machine can not be available any more.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
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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.
Young-Jae Cho, MPH study chair
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Gyeonggi, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Quality Sleep and Sleep Deprivation, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 5 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 23 Apr 2019. 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 South Korea. 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.
Are results available for this study?
The study was stopped early (reason given: The portable PSG machine can not be available any more.). 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?
The differences of sleep stage, sleep efficiency, arousal index and delirium between dexmedetomidine group and midazolam group (time frame: during ICU stay). 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 23 Apr 2019.