Effect of Sleep on the Recovery of Patients Admitted to the ICU

NCT04111900 | Completed

• 1 other identifier: 16111002
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to create several sleep/circadian rhythm friendly rooms within the medical intensive care unit to determine if decreasing sleep fragmentation effects recovery in patients hospitalized in the ICU.

Conditions

Critical Illness; Circadian Dysregulation; Delirium

Outcome Measures

Primary Outcomes (5)

• Length of Stay in ICU

  Time spent from admission to ICU until transfer/discharge or study cessation

  through study completion, an average of 3-4 days

• Overall Hospital Length of Stay

  Total time spent from admission to ICU until discharge from hospital

  at study completion, an average of 5-7 days

• Rate of ICU mortality

  rate of mortality while admitted to ICU

  at study completion, up to 30 days

• Rate of Delirium

  Assess development of delirium through administration of CAM-ICU and RASS performed daily by nursing staff per routine care. Delirium will be considered present if CAM-ICU is positive or RASS above +1 or below -1 at anytime during study.

  Once daily throughout study, on average 3-4 days

• Hospital Readmission Rate

  rate of hospital readmission within 30-days of discharge

  30 days after discharge

Secondary Outcomes (6)

• ICU sleep score

  daily through study completion, an average of 3-4 days

• Overnight Sound Intensity Levels

  through study completion, an average of 3-4 days

• Overnight Light Intensity Exposure

  through study completion, an average of 3-4 days

• Concentration of Interleukin-6 (IL-6) and interleukin-10 (IL-10)

  Study Day 1 and Day 2

• Concentration of 6-sulphatoxymelatonin (aMT6s)

  Study Day 1 and Day 2

Study Arms (2)

Sleep/Circadian Friendly

EXPERIMENTAL

initiation of sleep/circadian rhythm friendly intervention the first night spent in MICU after enrollment until patient transfers/discharges, ceases participation, or meets exclusion criteria.

Behavioral: Sleep/Circadian Friendly

Usual Care

NO INTERVENTION

Usual care within intensive care unit

Interventions

Sleep/Circadian Friendly BEHAVIORAL

This intervention attempts to improve sleep and prevent circadian rhythm dysregulation among patients admitted to the medical intensive care unit (MICU). Patients within his arm will be asked to try to keep their TV off and limit their telephone use from 10pm-7am, as well as limit the amount of visitors in their room as much as possible between those hours. Patients will also be offered ear plugs and eye masks if they wish to use at night to aid in helping them sleep, if deemed medically safe to do so. Additionally nurses will be asked to bathe patients either before 10pm or after 7am, to limit their conversations in the patient's room at night, and try as much as possible to limit blood draws and waking patients during those hours as is medically safe. Nurses will also be instructed to lower the blinds in the room at 10 pm and raise them up at 7am to help with patients sleep/wake cycle.

Sleep/Circadian Friendly

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any adult patient admitted to the MICU with an expected length of stay of at least 3 days

You may not qualify if:

• frequent overnight neurological checks or frequent peripheral vascular checks

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Critical Illness; Chronobiology Disorders; Delirium

Interventions

Sleep

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Garth R Swanson, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: October 1, 2019
• Study Start: February 27, 2017
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (1)