Neurobehavioral ManifestationsNCT01061242
Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance
A study testing Sleep promoting interventions in people with Neurobehavioral Manifestations and Sleep Deprivation, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to understand patients' neurocognitive performance shortly after discharge from the Medical Intensive Care Unit (MICU) and the potential effect of sleep quality in the MICU on those neurocognitive outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurobehavioral Manifestations, Sleep Deprivation, Dyssomnias
- What is being tested?
- Sleep promoting interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2010
- Phase
- Interventional
- 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
- >=18 years old
- Spent at least one full night (i.e. 7pm to 7am) in the Johns Hopkins Hospital (JHH) Medical Intensive Care Unit (MICU).
- Discharged directly from MICU to an in-patient medical step-down or ward bed at JHH.
Who cannot join
- Previously enrolled in the study (i.e. repeat discharge from MICU)
- Pre-existing cognitive impairment, including hepatic encephalopathy, long-term alcohol abuse, and neurological disease (e.g., dementia, prior stroke, cerebral palsy, traumatic brain injury, active seizures)
- Unable to speak and/or understand English
- > 96 hours between MICU discharge and testing
- Visual or hearing impairment, inability to read, or inability to use a writing instrument preventing administration of the neurocognitive tests
- Spent at least one night in an ICU other than JHH MICU during current hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-ICU Neurocognitive Performance and Sleep Quality Ratings Following Exposure to a Medical ICU Sleep Quality Improvement Project
The purpose of this study is to understand patients' neurocognitive performance shortly after discharge from the Medical Intensive Care Unit (MICU) and the potential effect of sleep quality in the MICU on those neurocognitive outcomes. The investigators hypothesize that post-ICU neurocognitive function and patient overall ICU sleep experience will improve through a pre-existing MICU sleep improvement initiative.
Read the detailed description
Despite decades of scientific interest in evaluating sleep among critically ill patients, little is known about the effects of intensive care unit (ICU)-associated sleep disturbances on patient outcomes. Furthermore, few interventions have been rigorously evaluated to demonstrate efficacy in improving sleep in the ICU and associated patient outcomes. Post-ICU neurocognitive test performance data from this study will be linked to a pre-existing Quality Improvement (QI) project for patient sleep in the MICU. We hypothesize that patients' post-ICU neurocognitive performance (delirium status, attention, short-term memory, processing speed, and executive function) will positively correlate with scores from a previously-published Sleep in the Intensive Care Unit Questionnaire. In addition, we hypothesize that both neurocognitive performance and the Sleep in the Intensive Care Unit Questionnaire will improve during the multi-stage MICU-wide sleep QI project. Our project will provide valuable empirical evidence to help support guidelines for promoting sleep in the ICU setting.
- Being tested
- Sleep promoting interventions
- Keywords
- Neurocognitive function, Sleep quality, Critical care, Quality Assurance, health care
- Medical subject headings
- Neurobehavioral Manifestations, Sleep Deprivation, Dyssomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep promoting interventionsBehavioural
MICU staff will implement multi-faceted, staged sleep promoting interventions as part of a pre-existing sleep quality improvement project.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | Post-Intensive Care Unit (ICU) neurocognitive testing and sleep survey performed on patients exposed to ad-lib Medical ICU environment. |
| Sleep Promotion Group | Experimental | Post-ICU neurocognitive testing and sleep survey performed on patients exposed to interventions in the pre-existing MICU sleep quality improvement project. Receives: Behavioral: Sleep promoting interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digit span test score
Measured: within 96 hours of Intensive Care Unit (ICU) discharge
Secondary outcomes (3)
Sleep in the ICU Questionnaire
Measured: within 96 hours of ICU discharge
Trail Making Test (Part A + B) times
Measured: within 96 hours of ICU discharge
Delirium status
Measured: within 96 hours of ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurobehavioral ManifestationsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061242
- Sponsor's protocol ID
- NA_00033951
- Status last verified
- Dec 2009
- First submitted
- 2 Feb 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-ICU Neurocognitive Performance and Sleep Quality Ratings Following Exposure to a Medical ICU Sleep Quality Improvement Project
- ClinicalTrials.gov ID
- NCT01061242
- Acronym / sponsor ID
- NA_00033951
- Keywords
- Neurocognitive function, Sleep quality, Critical care, Quality Assurance, health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Feb 2010 (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 understand patients' neurocognitive performance shortly after discharge from the Medical Intensive Care Unit (MICU) and the potential effect of sleep quality in the MICU on those neurocognitive outcomes. The investigators hypothesize that post-ICU neurocognitive function and patient overall ICU sleep experience will improve through a pre-existing MICU sleep improvement initiative.
Detailed description
Despite decades of scientific interest in evaluating sleep among critically ill patients, little is known about the effects of intensive care unit (ICU)-associated sleep disturbances on patient outcomes. Furthermore, few interventions have been rigorously evaluated to demonstrate efficacy in improving sleep in the ICU and associated patient outcomes. Post-ICU neurocognitive test performance data from this study will be linked to a pre-existing Quality Improvement (QI) project for patient sleep in the MICU. We hypothesize that patients' post-ICU neurocognitive performance (delirium status, attention, short-term memory, processing speed, and executive function) will positively correlate with scores from a previously-published Sleep in the Intensive Care Unit Questionnaire. In addition, we hypothesize that both neurocognitive performance and the Sleep in the Intensive Care Unit Questionnaire will improve during the multi-stage MICU-wide sleep QI project. Our project will provide valuable empirical evidence to help support guidelines for promoting sleep in the ICU setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Post-Intensive Care Unit (ICU) neurocognitive testing and sleep survey performed on patients exposed to ad-lib Medical ICU environment. |
| Sleep Promotion Group | Experimental | Behavioral: Sleep promoting interventionsPost-ICU neurocognitive testing and sleep survey performed on patients exposed to interventions in the pre-existing MICU sleep quality improvement project. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >=18 years old
- Spent at least one full night (i.e. 7pm to 7am) in the Johns Hopkins Hospital (JHH) Medical Intensive Care Unit (MICU).
- Discharged directly from MICU to an in-patient medical step-down or ward bed at JHH.
Key exclusion criteria (6 listed)
- Previously enrolled in the study (i.e. repeat discharge from MICU)
- Pre-existing cognitive impairment, including hepatic encephalopathy, long-term alcohol abuse, and neurological disease (e.g., dementia, prior stroke, cerebral palsy, traumatic brain injury, active seizures)
- Unable to speak and/or understand English
- > 96 hours between MICU discharge and testing
- Visual or hearing impairment, inability to read, or inability to use a writing instrument preventing administration of the neurocognitive tests
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 |
|---|---|---|
| Sleep promoting interventionsMICU staff will implement multi-faceted, staged sleep promoting interventions as part of a pre-existing sleep quality improvement project. | Behavioural | Sleep Promotion Group |
Primary outcome
Digit span test score
Time frame: within 96 hours of Intensive Care Unit (ICU) discharge
3 secondary outcomes
Sleep in the ICU Questionnaire
Time frame: within 96 hours of ICU discharge
Trail Making Test (Part A + B) times
Time frame: within 96 hours of ICU discharge
Delirium status
Time frame: within 96 hours of ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
Related trials for Neurobehavioral Manifestations
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
Enrolling by invitation
Brain Stimulation Paired With Structured Reading Instruction in Children With Dyslexia
Dyslexia, Reading Disability
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep promoting interventions in people with Neurobehavioral Manifestations and Sleep Deprivation, run by Johns Hopkins University 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 23 Jun 2011. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Digit span test score (time frame: within 96 hours of Intensive Care Unit (ICU) discharge). 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 Jun 2011.