Sleep DeprivationNCT03313115
Sleep/Wake Protocol Implementation to Improve Sleep Quality in the ICU
An observational study of Sleep Deprivation and Delirium, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to analyze a multi-component sleep/wake protocol for optimization of environmental factors (noise, light, nursing activities) as well as non-environmental factors (pain, mechanical support devices, procedures) to improve quality of sleep and decrease incidence of ICU delirium in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Deprivation, Delirium
- What is being tested?
- Sleep/Wake Protocol
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 685 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2017to 14 Mar 2018
- 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: Study participants will be drawn from those admitted into the Cardiovascular or Surgical Intensive Care Units at the University of Utah University Hospital
Who may be able to join
- Age 18 or older
- Admitted to the cardiovascular or surgical ICU
Who cannot join
- Patient acuity does not allow nighttime activities to be grouped (i.e., patient requires frequent bedside care throughout the night, as evaluated by registered nurse)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep/Wake Protocol Implementation to Improve Sleep Quality and Reduce Delirium in a Surgical and Cardiovascular Intensive Care Unit
The purpose of this study is to analyze a multi-component sleep/wake protocol for optimization of environmental factors (noise, light, nursing activities) as well as non-environmental factors (pain, mechanical support devices, procedures) to improve quality of sleep and decrease incidence of ICU delirium in the Cardiovascular and Surgical ICU (CVICU/SICU).
Read the detailed description
Fifty-percent of ICU patient sleep hours occur during the day in short bouts which decreases overall sleep quality. Approximately 47-87% of critically ill patients in the ICU experience an episode of delirium, which can result in changes in cognition, longer hospital stay, and physiologic consequences. Research suggests that both patients and staff members can identify environmental factors, such as noise, light, and nursing activities, as well as non-environmental factors such as mechanical devices, procedures, and medications as contributing factors to lack of sleep. However, both nursing staff and providers may underestimate the intensity of the perceived noise in the ICU. This includes those frequent nighttime interruptions, of environmental and non-environmental origins, which can cause fragmented sleep. Providers and nurses are aware of the factors contributing to sleep deprivation, but they may "lower prioritization of patient sleep [as a] tradeoff [for] current standard of care."
Studies have shown that sleep deprivation in critically ill patients can lead to changes in patient cognition, increased hospital and ICU length of stay, and physiologic consequences. These consequences are influenced from patient clinical status as well as modifiable risk factors. One study identified that barriers to the optimization of sleep include patient disease severity, mechanical ventilation, sedation, noise, light, and nurse-patient interaction. It identified a possible association between lack of sleep and cognition with additional consequences of longer mechanical ventilator time, and cardiovascular, pulmonary, and immune system dysfunctions.
Implementation of a protocol directed at optimizing environmental and non-environmental factors has been shown to improve patients' perceived and actual quality of sleep as well as a reduction in ICU delirium.
Another study studied sleep and delirium in a medical ICU after implementation of sleep-promoting interventions. Interventions aimed at reducing light, noise, nursing interruptions, and sedating medications were applied in a three-part process. Patients were surveyed using the Richards-Campbell Sleep Questionnaire and delirium was measured by delirium/coma-free days. Post-interventions resulted in an increase in delirium/coma-free days and an improvement in the amount of perceived noise.
One research group implemented a similar bundle that was aimed at improvement of sleep and delirium in both medical and surgical ICU patients. Their efforts were directed towards reduction in environmental factors as well as avoidance of sedating medications and long mechanical ventilator times. The Richards-Campbell Sleep Questionnaire was used to survey patients on quality of sleep and the Confusion Assessment Method for the ICU was measured daily for incidence of delirium. They found that patients' perceived quality of sleep increased with decreased daytime sleepiness as well as reductions in noise, light, and nursing interventions. Furthermore, they found that implementation of this bundle led to a decrease in length of delirium.
- Conditions
- Sleep Deprivation, Delirium
- Being tested
- Sleep/Wake Protocol
- Medical subject headings
- Sleep Deprivation, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep/Wake ProtocolBehavioural
Day RN observes if completed per pt: no caffeine after 3 pm, encourage activities to prevent napping (chart % day spent napping), Lights on blinds/door open, Reasonable effort for some noise in room, Eye glasses hearing aids applied, Chair position/mobility at least 2x30 minutes.
Night RN observe if completed per pt: Appropriate pain control, Optimize room temp, Warm bath before 2200, TV off by 2200, Prevent extra alarms after 2200, Close room curtain by 2200, Dim room lights by 2200, Family out by 2200, Door half/fully closed after 2200, # RN interruptions after 2200, Offer eye mask/ear plugs, Meds administered for sleep (dilaudid, fentanyl oxycodone, haldol, quetiapine, propofol, melatonin, or other), Dim hallway lights by 2200, Nurses station quiet
| Study group | Role | What they receive |
|---|---|---|
| No Sleep/Wake Protocol Implementation | No implementation of the sleep/wake protocol. A subset of participants in this group will have light and sound levels in the room recorded. | |
| Sleep/Wake Protocol Implementation | The sleep/wake protocol will be implemented. A subset of participants in this group will also have light and sound levels in the room recorded. Receives: Behavioral: Sleep/Wake Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ICU delirium
Participants will be evaluated for delirium using the Confusion Assessment Method for the ICU (CAM-ICU)
Measured: Two times daily until ICU discharge (up to 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start11 Oct 2017
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 685 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Tonna, MD, FAAEM, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313115
- Sponsor's protocol ID
- 104449
- Status last verified
- Feb 2020
- First submitted
- 11 Oct 2017
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beltrami FG, Nguyen XL, Pichereau C, Maury E, Fleury B, Fagondes S. Sleep in the intensive care unit. J Bras Pneumol. 2015 Nov-Dec;41(6):539-46. doi: 10.1590/S1806-37562015000000056.
PubMed 26785964Bihari S, Doug McEvoy R, Matheson E, Kim S, Woodman RJ, Bersten AD. Factors affecting sleep quality of patients in intensive care unit. J Clin Sleep Med. 2012 Jun 15;8(3):301-7. doi: 10.5664/jcsm.1920.
PubMed 22701388Cavallazzi R, Saad M, Marik PE. Delirium in the ICU: an overview. Ann Intensive Care. 2012 Dec 27;2(1):49. doi: 10.1186/2110-5820-2-49.
PubMed 23270646Giusti GD, Tuteri D, Giontella M. Nursing Interactions With Intensive Care Unit Patients Affected by Sleep Deprivation: An Observational Study. Dimens Crit Care Nurs. 2016 May-Jun;35(3):154-9. doi: 10.1097/DCC.0000000000000177.
PubMed 27043401Hata RK, Han L, Slade J, Miyahira A, Passion C, Ghows M, Izumi K, Yu M. Promoting sleep in the adult surgical intensive care unit patients to prevent delirium. Nurs Clin North Am. 2014 Sep;49(3):383-97. doi: 10.1016/j.cnur.2014.05.012.
PubMed 25155537Hopper K, Fried TR, Pisani MA. Health care worker attitudes and identified barriers to patient sleep in the medical intensive care unit. Heart Lung. 2015 Mar-Apr;44(2):95-9. doi: 10.1016/j.hrtlng.2015.01.011. Epub 2015 Feb 14.
PubMed 25686516Kamdar BB, Needham DM, Collop NA. Sleep deprivation in critical illness: its role in physical and psychological recovery. J Intensive Care Med. 2012 Mar-Apr;27(2):97-111. doi: 10.1177/0885066610394322. Epub 2011 Jan 10.
PubMed 21220271Kamdar BB, King LM, Collop NA, Sakamuri S, Colantuoni E, Neufeld KJ, Bienvenu OJ, Rowden AM, Touradji P, Brower RG, Needham DM. The effect of a quality improvement intervention on perceived sleep quality and cognition in a medical ICU. Crit Care Med. 2013 Mar;41(3):800-9. doi: 10.1097/CCM.0b013e3182746442.
PubMed 23314584Patel J, Baldwin J, Bunting P, Laha S. The effect of a multicomponent multidisciplinary bundle of interventions on sleep and delirium in medical and surgical intensive care patients. Anaesthesia. 2014 Jun;69(6):540-9. doi: 10.1111/anae.12638.
PubMed 24813132Pulak LM, Jensen L. Sleep in the Intensive Care Unit: A Review. J Intensive Care Med. 2016 Jan;31(1):14-23. doi: 10.1177/0885066614538749. Epub 2014 Jun 10.
PubMed 24916753Ritmala-Castren M, Virtanen I, Leivo S, Kaukonen KM, Leino-Kilpi H. Sleep and nursing care activities in an intensive care unit. Nurs Health Sci. 2015 Sep;17(3):354-61. doi: 10.1111/nhs.12195. Epub 2015 Mar 18.
PubMed 25786544Weinhouse GL, Schwab RJ. Sleep in the critically ill patient. Sleep. 2006 May;29(5):707-16. doi: 10.1093/sleep/29.5.707.
PubMed 16774162White BL, Zomorodi M. Perceived and actual noise levels in critical care units. Intensive Crit Care Nurs. 2017 Feb;38:18-23. doi: 10.1016/j.iccn.2016.06.004. Epub 2016 Aug 25.
PubMed 27567305Tonna JE, Dalton A, Presson AP, Zhang C, Colantuoni E, Lander K, Howard S, Beynon J, Kamdar BB. The Effect of a Quality Improvement Intervention on Sleep and Delirium in Critically Ill Patients in a Surgical ICU. Chest. 2021 Sep;160(3):899-908. doi: 10.1016/j.chest.2021.03.030. Epub 2021 Mar 24.
PubMed 33773988
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep/Wake Protocol Implementation to Improve Sleep Quality and Reduce Delirium in a Surgical and Cardiovascular Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03313115
- Acronym / sponsor ID
- 104449
- Conditions
- Sleep Deprivation, Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 685 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 18 Oct 2017 (actual)
- 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 analyze a multi-component sleep/wake protocol for optimization of environmental factors (noise, light, nursing activities) as well as non-environmental factors (pain, mechanical support devices, procedures) to improve quality of sleep and decrease incidence of ICU delirium in the Cardiovascular and Surgical ICU (CVICU/SICU).
Detailed description
Fifty-percent of ICU patient sleep hours occur during the day in short bouts which decreases overall sleep quality. Approximately 47-87% of critically ill patients in the ICU experience an episode of delirium, which can result in changes in cognition, longer hospital stay, and physiologic consequences. Research suggests that both patients and staff members can identify environmental factors, such as noise, light, and nursing activities, as well as non-environmental factors such as mechanical devices, procedures, and medications as contributing factors to lack of sleep. However, both nursing staff and providers may underestimate the intensity of the perceived noise in the ICU. This includes those frequent nighttime interruptions, of environmental and non-environmental origins, which can cause fragmented sleep. Providers and nurses are aware of the factors contributing to sleep deprivation, but they may "lower prioritization of patient sleep [as a] tradeoff [for] current standard of care."
Studies have shown that sleep deprivation in critically ill patients can lead to changes in patient cognition, increased hospital and ICU length of stay, and physiologic consequences. These consequences are influenced from patient clinical status as well as modifiable risk factors. One study identified that barriers to the optimization of sleep include patient disease severity, mechanical ventilation, sedation, noise, light, and nurse-patient interaction. It identified a possible association between lack of sleep and cognition with additional consequences of longer mechanical ventilator time, and cardiovascular, pulmonary, and immune system dysfunctions.
Implementation of a protocol directed at optimizing environmental and non-environmental factors has been shown to improve patients' perceived and actual quality of sleep as well as a reduction in ICU delirium.
Another study studied sleep and delirium in a medical ICU after implementation of sleep-promoting interventions. Interventions aimed at reducing light, noise, nursing interruptions, and sedating medications were applied in a three-part process. Patients were surveyed using the Richards-Campbell Sleep Questionnaire and delirium was measured by delirium/coma-free days. Post-interventions resulted in an increase in delirium/coma-free days and an improvement in the amount of perceived noise.
One research group implemented a similar bundle that was aimed at improvement of sleep and delirium in both medical and surgical ICU patients. Their efforts were directed towards reduction in environmental factors as well as avoidance of sedating medications and long mechanical ventilator times. The Richards-Campbell Sleep Questionnaire was used to survey patients on quality of sleep and the Confusion Assessment Method for the ICU was measured daily for incidence of delirium. They found that patients' perceived quality of sleep increased with decreased daytime sleepiness as well as reductions in noise, light, and nursing interventions. Furthermore, they found that implementation of this bundle led to a decrease in length of delirium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Sleep/Wake Protocol Implementation | – | –No implementation of the sleep/wake protocol. A subset of participants in this group will have light and sound levels in the room recorded. |
| Sleep/Wake Protocol Implementation | – | Behavioral: Sleep/Wake ProtocolThe sleep/wake protocol will be implemented. A subset of participants in this group will also have light and sound levels in the room recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be drawn from those admitted into the Cardiovascular or Surgical Intensive Care Units at the University of Utah University Hospital
Key inclusion criteria (2 listed)
- Age 18 or older
- Admitted to the cardiovascular or surgical ICU
Key exclusion criteria (1 listed)
- Patient acuity does not allow nighttime activities to be grouped (i.e., patient requires frequent bedside care throughout the night, as evaluated by registered nurse)
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/Wake ProtocolDay RN observes if completed per pt: no caffeine after 3 pm, encourage activities to prevent napping (chart % day spent napping), Lights on blinds/door open, Reasonable effort for some noise in room, Eye glasses hearing aids applied, Chair position/mobility at least 2x30 minutes. Night RN observe if completed per pt: Appropriate pain control, Optimize room temp, Warm bath before 2200, TV off by 2200, Prevent extra alarms after 2200, Close room curtain by 2200, Dim room lights by 2200, Family out by 2200, Door half/fully closed after 2200, # RN interruptions after 2200, Offer eye mask/ear plugs, Meds administered for sleep (dilaudid, fentanyl oxycodone, haldol, quetiapine, propofol, melatonin, or other), Dim hallway lights by 2200, Nurses station quiet | Behavioural | Sleep/Wake Protocol Implementation |
Primary outcome
Incidence of ICU delirium
Time frame: Two times daily until ICU discharge (up to 4 months)
Participants will be evaluated for delirium using the Confusion Assessment Method for the ICU (CAM-ICU)
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 25 Apr 2023.
- Background: PubMed 26785964Beltrami FG, Nguyen XL, Pichereau C, Maury E, Fleury B, Fagondes S. Sleep in the intensive care unit. J Bras Pneumol. 2015 Nov-Dec;41(6):539-46. doi: 10.1590/S1806-37562015000000056.
- Background: PubMed 22701388Bihari S, Doug McEvoy R, Matheson E, Kim S, Woodman RJ, Bersten AD. Factors affecting sleep quality of patients in intensive care unit. J Clin Sleep Med. 2012 Jun 15;8(3):301-7. doi: 10.5664/jcsm.1920.
- Background: PubMed 23270646Cavallazzi R, Saad M, Marik PE. Delirium in the ICU: an overview. Ann Intensive Care. 2012 Dec 27;2(1):49. doi: 10.1186/2110-5820-2-49.
- Background: PubMed 27043401Giusti GD, Tuteri D, Giontella M. Nursing Interactions With Intensive Care Unit Patients Affected by Sleep Deprivation: An Observational Study. Dimens Crit Care Nurs. 2016 May-Jun;35(3):154-9. doi: 10.1097/DCC.0000000000000177.
- Background: PubMed 25155537Hata RK, Han L, Slade J, Miyahira A, Passion C, Ghows M, Izumi K, Yu M. Promoting sleep in the adult surgical intensive care unit patients to prevent delirium. Nurs Clin North Am. 2014 Sep;49(3):383-97. doi: 10.1016/j.cnur.2014.05.012.
- Background: PubMed 25686516Hopper K, Fried TR, Pisani MA. Health care worker attitudes and identified barriers to patient sleep in the medical intensive care unit. Heart Lung. 2015 Mar-Apr;44(2):95-9. doi: 10.1016/j.hrtlng.2015.01.011. Epub 2015 Feb 14.
- Background: PubMed 21220271Kamdar BB, Needham DM, Collop NA. Sleep deprivation in critical illness: its role in physical and psychological recovery. J Intensive Care Med. 2012 Mar-Apr;27(2):97-111. doi: 10.1177/0885066610394322. Epub 2011 Jan 10.
- Background: PubMed 23314584Kamdar BB, King LM, Collop NA, Sakamuri S, Colantuoni E, Neufeld KJ, Bienvenu OJ, Rowden AM, Touradji P, Brower RG, Needham DM. The effect of a quality improvement intervention on perceived sleep quality and cognition in a medical ICU. Crit Care Med. 2013 Mar;41(3):800-9. doi: 10.1097/CCM.0b013e3182746442.
- Background: PubMed 24813132Patel J, Baldwin J, Bunting P, Laha S. The effect of a multicomponent multidisciplinary bundle of interventions on sleep and delirium in medical and surgical intensive care patients. Anaesthesia. 2014 Jun;69(6):540-9. doi: 10.1111/anae.12638.
- Background: PubMed 24916753Pulak LM, Jensen L. Sleep in the Intensive Care Unit: A Review. J Intensive Care Med. 2016 Jan;31(1):14-23. doi: 10.1177/0885066614538749. Epub 2014 Jun 10.
- Background: PubMed 25786544Ritmala-Castren M, Virtanen I, Leivo S, Kaukonen KM, Leino-Kilpi H. Sleep and nursing care activities in an intensive care unit. Nurs Health Sci. 2015 Sep;17(3):354-61. doi: 10.1111/nhs.12195. Epub 2015 Mar 18.
- Background: PubMed 16774162Weinhouse GL, Schwab RJ. Sleep in the critically ill patient. Sleep. 2006 May;29(5):707-16. doi: 10.1093/sleep/29.5.707.
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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.
Joseph Tonna, MD, FAAEM principal investigator
University of Utah
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 Sleep Deprivation and Delirium, run by University of Utah 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 2 inclusion and 1 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 25 Apr 2023. 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?
Incidence of ICU delirium (time frame: Two times daily until ICU discharge (up to 4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03313115, which also lists 14 linked publications.
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 25 Apr 2023.