Creating Naptime: An Overnight, Non-Pharmacologic Intensive Care Unit Sleep Promotion Protocol

NCT ID: NCT03119207

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-04
• Study Completion Date: 2014-06-22

Brief Summary

Specific Aims:

1. Quantify baseline patient room disruptions in the medical ICU during the proposed nocturnal Naptime .

1. Obtain baseline light and noise levels in selected medical ICU study rooms.

2. Obtain baseline activity level levels in selected medical ICU study rooms.

3. Assess baseline information regarding nursing experience, prior training / beliefs regarding sleep promotion in the medical ICU

2. Assess the feasibility of instituting a 4 hour (Midnight to 4:00 AM) nocturnal Naptime with minimization of patient interaction via tracking of differences in patient room activity, light and noise levels in control versus intervention patients.

Secondary Aim

3. Examine the associations between Naptime provision and patient sleep quality.

Detailed Description

The effects of poor sleep are dauntingly pleiotropic. Inasmuch as sleep deprivation can behaviorally and physiologically mimic delirium in the ICU, there is concern that sleep deprived ICU patients are at risk for the increased mortality, longer hospital stays and worsened physical and mental outcomes of hospitalized patients who experience delirium during their admission. Furthermore, lack of sleep has been associated with decrements in FEV1, FVC and maximal inspiratory pressure in non-ICU COPD patients, increases in respiratory muscle fatigue in healthy volunteers and blunted response to hypercapnea in healthy volunteers. Finally, theoretical concerns exist regarding sleep loss putting patients at risk for prolonged bedrest, adverse cardiovascular events, derangement of metabolism and endocrine function as well as immune suppression; though supported by animal models and brief studies in healthy volunteers, no ICU data exists.

Conditions

Sleep

Study Design

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

Study Groups

Naptime Participants

The participants will undergo the Naptime Protocol. The study team will provide a 4 hour period nightly during which patient room activity, light levels and noise levels will be decreased. The team will monitor the changes in the number and quality of these disruptions and to monitor the changes in patient sleep and outcome following our intervention.

Group Type: EXPERIMENTAL

Naptime Protocol

Intervention Type: BEHAVIORAL

Between midnight and 4:00 every attempt will be made to limit staff entrance into the patient room.

Control Participants

Naptime will not be enforced. Patient room activity, light levels and noise levels are monitored. Standard care will be provided. During the intervention period patients are randomized to either control or naptime.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Baseline Participants

Prior to the intervention period, baseline patients under usual care are monitored. Naptime will not be enforced. Patient room activity, light levels and noise levels are monitored.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Naptime Protocol

Between midnight and 4:00 every attempt will be made to limit staff entrance into the patient room.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All MICU admissions age 18 and older who are admitted no less than 6 hours and no more than 48 hours prior to intended start of the next potential Naptime (midnight start).

Exclusion Criteria

• Patients who are "boarding" from other intensive care units at Yale New Haven Hospital; these patients are not cared for by our providers and would not be subject to our protocols.
• Patients without an identifiable surrogate who cannot consent for themselves.
• Comfort care only patients
• Patients undergoing the hypothermia protocol.
• Patients enrolled in the MIND*USA delirium study.
• Non-English speaking patients

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

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Knauert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Other Identifiers

P20NR014126

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1112009428

Identifier Type: -

Identifier Source: org_study_id