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

NCT ID: NCT04111900

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2020-01-31

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.

Detailed Description

Critically ill patients are known to suffer from severely fragmented sleep with a predominance of stage I sleep and a paucity of slow wave and REM sleep. The causes of this sleep disruption include the intensive care unit (ICU) environment, medical illness, psychological stress, and many of the medications and other treatments used to help those who are critically ill. Surveys have identified poor sleep as one of the most frequent complaints among patients who have survived a critical illness. Patients in medical, cardiac, and surgical ICUs almost uniformly have fragmented sleep.

Although illness, pain, and medications contribute to sleep disruption in ICU patients, the primary factor causing sleep disruption had been thought to be the ICU environment. Noise from various sources, including ventilators, alarms, television, phones, beepers, and conversation, have all been purported to disturb sleep in the ICU. Patients have reported that noise, specifically talking, is a frequent cause of sleep disruption in the ICU. Several studies have confirmed that peak noise levels in ICUs are far in excess of 45 dB during the day and 35 dB at night, which are the recommendations of the Environmental Protection Agency for peak noise levels in the ICU.

The clinical importance of this type of sleep disruption in critically ill patients, however, is not known. The investigators hope to determine if placing patients in sleep/circadian rhythm friendly rooms will enable them to achieve better sleep, suffer from decreased delirium, and have improved recovery from their critical illness.

Conditions

Critical Illness; Circadian Dysregulation; Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sleep/Circadian Friendly

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.

Group Type: EXPERIMENTAL

Sleep/Circadian Friendly

Intervention Type: 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.

Usual Care

Usual care within intensive care unit

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sleep/Circadian Friendly

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• frequent overnight neurological checks or frequent peripheral vascular checks

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Garth R Swanson, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

16111002

Identifier Type: -

Identifier Source: org_study_id