Respiratory FailureNCT01276652
Sleep and Circadian Rhythms in Mechanically Ventilated Patients
A study testing Environmental modification in people with Respiratory Failure and Critical Illness, run by University of Iowa at 1 site in United States.
Trial summary
This study examines the feasibility of assessing sleep and circadian rhythmicity in critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the feasibility of reducing subject exposure to environmental light and noise and of delivering routine care according to classical day/night… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Critical Illness
- What is being tested?
- Environmental modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults undergoing mechanical ventilation in the medical intensive care unit.
Who cannot join
- Central nervous system disease (stroke, seizure, dementia, etc)
- Metabolic or hypoxic encephalopathy
- Confirmed or suspected drug overdose
- Currently receiving neuromuscular blockers
- Coma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep and Circadian Rhythms in Mechanically Ventilated Patients: a Feasibility and Mechanistic Study.
This study examines the feasibility of assessing sleep and circadian rhythmicity in critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the feasibility of reducing subject exposure to environmental light and noise and of delivering routine care according to classical day/night routines.
Read the detailed description
Over 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This protocol enrolls acutely ill medical patients undergoing mechanical ventilation. The feasibility of assessing sleep and circadian rhythmicity through the use of continuous bedside polysomnography and the measurement of core body temperature and urinary hormonal levels at frequent intervals will be explored. As a secondary goal, the feasibility of delivering routine care according to classical day/night routines, and of employing various noise and light reduction strategies at night, will be explored in a subset of subjects.
- Conditions
- Respiratory Failure, Critical Illness
- Being tested
- Environmental modification
- Keywords
- Polysomnography, Circadian rhythmicity
- Medical subject headings
- Respiratory Insufficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental modificationBehavioural
Environmental modification consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
| Study group | Role | What they receive |
|---|---|---|
| Environmental modification | Active comparator | Subjects assigned to this group receive the environmental modification intervention for 48 hours beginning the morning after enrollment. Receives: Behavioral: Environmental modification |
| Usual care (randomized) | No intervention | Usual care is provided for the first 48 hours. Subsequently, in the initial protocol, subjects received 48 hours of the environmental modification intervention so long as they remained in the ICU during this time. The opportunity to receive the "Delayed" intervention was later removed from the protocol. |
| Usual care (observational) | No intervention | Usual care was provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.
This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients through the application of continuous bedside polysomnography. Feasibility will be assessed by determining the percentage of enrolled subjects who undergo at least 24 hours of continuous bedside polysomnography.
Measured: Average 4 days (patients followed to hospital discharge)
Secondary outcomes (1)
Subject Tolerance of the Environmental Modification Protocol
This outcome measure will examine, in a preliminary fashion, subject tolerance of the environmental modification protocol. Tolerance will be assessed through qualitative interviews performed by the PI with the subjects.
Measured: Average 4 days (patients followed to hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startNov 2001
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects were randomized in 1:1 fashion to receive the Environmental Modification protocol or usual care. Subsequently a third, observational arm was opened to acquire more physiologic data.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), The Brain Research Foundation, University of Chicago
- Responsible party
- Principal investigator, Brian Gehlbach, University of Iowa
- Investigators
- Brian K Gehlbach, MD, Principal investigator, University of ChicagoJesse Hall, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276652
- Sponsor's protocol ID
- SleepICU111
- Other IDs
- 5K23HL088020
- Status last verified
- Jul 2017
- First submitted
- 10 Jan 2011
- Last updated
- 26 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: As this is a pilot study, there are no plans to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Circadian Rhythms in Mechanically Ventilated Patients: a Feasibility and Mechanistic Study.
- ClinicalTrials.gov ID
- NCT01276652
- Acronym / sponsor ID
- SleepICU111
- Conditions
- Respiratory Failure, Critical Illness
- Keywords
- Polysomnography, Circadian rhythmicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), The Brain Research Foundation, University of Chicago
- Study start
- Nov 2001
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Posted 26 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the feasibility of assessing sleep and circadian rhythmicity in critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the feasibility of reducing subject exposure to environmental light and noise and of delivering routine care according to classical day/night routines.
Detailed description
Over 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This protocol enrolls acutely ill medical patients undergoing mechanical ventilation. The feasibility of assessing sleep and circadian rhythmicity through the use of continuous bedside polysomnography and the measurement of core body temperature and urinary hormonal levels at frequent intervals will be explored. As a secondary goal, the feasibility of delivering routine care according to classical day/night routines, and of employing various noise and light reduction strategies at night, will be explored in a subset of subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects were randomized in 1:1 fashion to receive the Environmental Modification protocol or usual care. Subsequently a third, observational arm was opened to acquire more physiologic data.
| Arm | Type | Receives |
|---|---|---|
| Environmental modification | Active comparator | Behavioral: Environmental modificationSubjects assigned to this group receive the environmental modification intervention for 48 hours beginning the morning after enrollment. |
| Usual care (randomized) | No intervention | –Usual care is provided for the first 48 hours. Subsequently, in the initial protocol, subjects received 48 hours of the environmental modification intervention so long as they remained in the ICU during this time. The opportunity to receive the "Delayed" intervention was later removed from the protocol. |
| Usual care (observational) | No intervention | –Usual care was provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults undergoing mechanical ventilation in the medical intensive care unit.
Key exclusion criteria (5 listed)
- Central nervous system disease (stroke, seizure, dementia, etc)
- Metabolic or hypoxic encephalopathy
- Confirmed or suspected drug overdose
- Currently receiving neuromuscular blockers
- Coma
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 |
|---|---|---|
| Environmental modificationEnvironmental modification consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night. | Behavioural | Environmental modification |
Primary outcome
Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.
Time frame: Average 4 days (patients followed to hospital discharge)
This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients through the application of continuous bedside polysomnography. Feasibility will be assessed by determining the percentage of enrolled subjects who undergo at least 24 hours of continuous bedside polysomnography.
1 secondary outcome
Subject Tolerance of the Environmental Modification Protocol
Time frame: Average 4 days (patients followed to hospital discharge)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. As this is a pilot study, there are no plans to share IPD.
Related trials for Respiratory Failure
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Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
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Mechanical Ventilator Adjustments and Patient Dyspnea
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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.
Brian K Gehlbach, MD principal investigator
University of Chicago
Jesse Hall, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental modification in people with Respiratory Failure and Critical Illness, run by University of Iowa 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 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: finished, as of the sponsor's last update on 26 Sep 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours. (time frame: Average 4 days (patients followed to hospital 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 26 Sep 2017.