Sleep DeprivationNCT01082016
Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit
A study testing Sleep Enhancement Program (SEP) in people with Sleep Deprivation, run by University of Arizona at 1 site in United States.
Trial summary
Sleep deprivation in healthy volunteers is associated with immune dysfunction. This adverse effect of sleep deprivation likely occurs in patients suffering from acute injury and critical illness requiring intensive care unit (ICU) admission. Studies have demonstrated that sleep in ICU patients is highly abnormal. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Sleep Enhancement Program (SEP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2013
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Received care in ICU for at least 3 days
- Received care in ICU no longer than 14 days
- Score of 3 to 5 on the Riker Sedation-Agitation Scale (SAS)
- Age < 55 years
- Able to tolerate PO or have gastric access present (Nasogastric/Orogastric/PEG)
Who cannot join
- Pregnancy
- Incarceration
- Admission diagnosis of Closed Head Injury or Traumatic Brain Injury
- Evidence of delirium on Confusion Assessment Method (CAM-ICU) Score
- Hemodynamic Instability
- Sepsis
Show all 10Show fewer
- Multiple Organ Dysfunction
- Acute Renal Failure
- Known history of sleep disorder
- Known Psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Sleep deprivation in healthy volunteers is associated with immune dysfunction. This adverse effect of sleep deprivation likely occurs in patients suffering from acute injury and critical illness requiring intensive care unit (ICU) admission. Studies have demonstrated that sleep in ICU patients is highly abnormal. The global hypothesis for this proposal is that a strategy to promote sleep in ICU patients will increase time in rapid eye movement (REM) and slow wave sleep (SWS). This three phase proposal examines the feasibility of a sleep promotion strategy for injured and critically ill patients in the ICU.
Phase I (Development and Training): Develop an intervention manual for sleep promotion, Sleep Enhancement Program (SEP), and train ICU staff.
Read more
Phase II (Validation and Safety): Implement SEP and test for protocol fidelity and safety.
Phase III (Efficacy): Conduct a pilot trail to determine efficacy of SEP to improve SWS in ICU patients.
- Conditions
- Sleep Deprivation
- Being tested
- Sleep Enhancement Program (SEP)
- Keywords
- Sleep, Critical Illness, Sleep promotion during recovery form illness
- Medical subject headings
- Sleep Deprivation, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Enhancement Program (SEP)Other
Sleep promotion in the ICU Multifaceted tool to promote sleep in ICU patients
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Monitor sleep in ICU without attempts at promotion |
| Sleep promotion | Experimental | Measure sleep in ICU with sleep promotion program in effect Receives: Other: Sleep Enhancement Program (SEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Rapid Eye Movement (REM) Sleep
Polysomnography during sleep promotion protocol
Measured: Within 24 hours of enrollment
Time in slow wave sleep
Polysomnography during sleep promotion protocol
Measured: Within 24 hours of enrollment
Secondary outcomes (2)
Systemic inflammatory mediators (cytokines)
Blood draw for circulating mediaotors of inflammation
Measured: Baseline and 12, 24, and 48 hours
Safety profile
Monitor for adverse events during polysomnography
Measured: With 24 hours of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona Biomedical Research Commission (ABRC)
- Investigators
- Randall S Friese, MD, Principal investigator, University of Arizona College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082016
- Sponsor's protocol ID
- ABRC 9-022
- Status last verified
- Mar 2010
- First submitted
- 4 Mar 2010
- Last updated
- 20 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parthasarathy S, Friese RS, Ayas NT. Biological validity to sleep measurements during critical illness. Crit Care Med. 2010 Feb;38(2):705-6. doi: 10.1097/CCM.0b013e3181cbb05f. No abstract available.
PubMed 20083935Friese RS. Good night, sleep tight: the time is ripe for critical care providers to wake up and focus on sleep. Crit Care. 2008;12(3):146. doi: 10.1186/cc6884. Epub 2008 May 12.
PubMed 18492219Friese RS, Diaz-Arrastia R, McBride D, Frankel H, Gentilello LM. Quantity and quality of sleep in the surgical intensive care unit: are our patients sleeping? J Trauma. 2007 Dec;63(6):1210-4. doi: 10.1097/TA.0b013e31815b83d7.
PubMed 18212640Friese RS. Sleep and recovery from critical illness and injury: a review of theory, current practice, and future directions. Crit Care Med. 2008 Mar;36(3):697-705. doi: 10.1097/CCM.0B013E3181643F29.
PubMed 18176314
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01082016
- Acronym / sponsor ID
- ABRC 9-022
- Conditions
- Sleep Deprivation
- Keywords
- Sleep, Critical Illness, Sleep promotion during recovery form illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Arizona Biomedical Research Commission (ABRC)
- Study start
- Apr 2010
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 5 Mar 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.
Sleep deprivation in healthy volunteers is associated with immune dysfunction. This adverse effect of sleep deprivation likely occurs in patients suffering from acute injury and critical illness requiring intensive care unit (ICU) admission. Studies have demonstrated that sleep in ICU patients is highly abnormal. The global hypothesis for this proposal is that a strategy to promote sleep in ICU patients will increase time in rapid eye movement (REM) and slow wave sleep (SWS). This three phase proposal examines the feasibility of a sleep promotion strategy for injured and critically ill patients in the ICU.
Phase I (Development and Training): Develop an intervention manual for sleep promotion, Sleep Enhancement Program (SEP), and train ICU staff.
Phase II (Validation and Safety): Implement SEP and test for protocol fidelity and safety.
Phase III (Efficacy): Conduct a pilot trail to determine efficacy of SEP to improve SWS in ICU patients.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Monitor sleep in ICU without attempts at promotion |
| Sleep promotion | Experimental | Other: Sleep Enhancement Program (SEP)Measure sleep in ICU with sleep promotion program in effect |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Received care in ICU for at least 3 days
- Received care in ICU no longer than 14 days
- Score of 3 to 5 on the Riker Sedation-Agitation Scale (SAS)
- Age < 55 years
- Able to tolerate PO or have gastric access present (Nasogastric/Orogastric/PEG)
Key exclusion criteria (10 listed)
- Pregnancy
- Incarceration
- Admission diagnosis of Closed Head Injury or Traumatic Brain Injury
- Evidence of delirium on Confusion Assessment Method (CAM-ICU) Score
- Hemodynamic Instability
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 Enhancement Program (SEP)Sleep promotion in the ICU Multifaceted tool to promote sleep in ICU patients | Other | Sleep promotion |
Primary outcome
Time in Rapid Eye Movement (REM) Sleep
Time frame: Within 24 hours of enrollment
Polysomnography during sleep promotion protocol
Time in slow wave sleep
Time frame: Within 24 hours of enrollment
Polysomnography during sleep promotion protocol
2 secondary outcomes
Systemic inflammatory mediators (cytokines)
Time frame: Baseline and 12, 24, and 48 hours
Safety profile
Time frame: With 24 hours of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2010.
- Background: PubMed 20083935Parthasarathy S, Friese RS, Ayas NT. Biological validity to sleep measurements during critical illness. Crit Care Med. 2010 Feb;38(2):705-6. doi: 10.1097/CCM.0b013e3181cbb05f. No abstract available.
- Background: PubMed 18492219Friese RS. Good night, sleep tight: the time is ripe for critical care providers to wake up and focus on sleep. Crit Care. 2008;12(3):146. doi: 10.1186/cc6884. Epub 2008 May 12.
- Background: PubMed 18212640Friese RS, Diaz-Arrastia R, McBride D, Frankel H, Gentilello LM. Quantity and quality of sleep in the surgical intensive care unit: are our patients sleeping? J Trauma. 2007 Dec;63(6):1210-4. doi: 10.1097/TA.0b013e31815b83d7.
- Background: PubMed 18176314Friese RS. Sleep and recovery from critical illness and injury: a review of theory, current practice, and future directions. Crit Care Med. 2008 Mar;36(3):697-705. doi: 10.1097/CCM.0B013E3181643F29.
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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.
Randall S Friese, MD principal investigator
University of Arizona College of Medicine
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 Enhancement Program (SEP) in people with Sleep Deprivation, run by University of Arizona 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Sep 2010. 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?
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 in Rapid Eye Movement (REM) Sleep (time frame: Within 24 hours of enrollment). The study lists 2 primary outcomes in all. 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 NCT01082016, which also lists 4 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 20 Sep 2010.