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

Study Overview
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Brief Summary
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Specific Aims: Quantify baseline patient room disruptions in the medical ICU during the proposed nocturnal Naptime . Obtain baseline light and noise levels in selected medical ICU study rooms. Obtain baseline activity level levels in selected medical ICU study rooms. Assess baseline information regarding nursing experience, prior training / beliefs regarding sleep promotion in the medical ICU 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 Examine the associations between Naptime provision and patient sleep quality.

Detailed Description
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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.

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

Conditions
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Sleep

Intervention / Treatment
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* Behavioral: Naptime Protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naptime Participants<br>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. | Behavioral: Naptime Protocol<br>* Between midnight and 4:00 every attempt will be made to limit staff entrance into the patient room.<br>|
| No Intervention: Control Participants<br>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. | |
| No Intervention: Baseline Participants<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sound Level | Sound levels in the patient room will be monitored overnight for the three nights following enrollment. Sound level recordings will include 8:00 PM to 12:00PM (noon) on the following day to track the Naptime period (12:00 AM/midnight to 4:00 AM) and adjacent control periods. | Day 1-3 following study enrollment | 
| Light Level | Light levels in the patient room will be monitored overnight for the three nights following enrollment. Light level recordings will include 8:00 PM to 12:00PM (noon) on the following day to track the Naptime period (12:00 AM/midnight to 4:00 AM) and adjacent control periods. | Day 1-3 following study enrollment | 
| Number of Room Entrances | The number of room entrances will be monitored overnight for the three nights following enrollment via videography of the room door. Videography will include 8:00 PM to 12:00PM (noon) on the following day to track the Naptime period (12:00 AM/midnight to 4:00 AM) and adjacent control periods. | Day 1-3 following study enrollment | 
| Length of Room Entrances | The length of room entrances will be monitored overnight for the three nights following enrollment via videography of the room door. Videography will include 8:00 PM to 12:00PM (noon) on the following day to track the Naptime period (12:00 AM/midnight to 4:00 AM) and adjacent control periods. | Day 1-3 following study enrollment | 
| Length of Rest Periods between Room Entrances | The length of rest periods between room entrances will be monitored overnight for the three nights following enrollment via videography of the room door. Videography will include 8:00 PM to 12:00PM (noon) on the following day to track the Naptime period (12:00 AM/midnight to 4:00 AM) and adjacent control periods. | Day 1-3 following study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RCSQ score | The Richards Campbell Sleep Questionnaire will be administered to all patients and their primary overnight nurses to evaluate sleep quality. | Day 1-3 following study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU