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

Not Applicable

Completed

• Conditions: Sleep
• Interventions: Behavioral: Naptime Protocol

• Registration Number: NCT03119207
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2012-11-04
• Primary Completion: 2014-06-22
• Study Completion: 2014-06-22
• Status Verified: 2017-04
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-17
• Last Update Submitted: 2017-04-17
• Study First Posted: 2017-04-18
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naptime Participants	Naptime Protocol	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.

Primary Outcome Measures

Name	Time	Method
Sound Level	Day 1-3 following study enrollment	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.
Light Level	Day 1-3 following study enrollment	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.
Length of Room Entrances	Day 1-3 following study enrollment	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.
Length of Rest Periods between Room Entrances	Day 1-3 following study enrollment	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.
Number of Room Entrances	Day 1-3 following study enrollment	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.

Secondary Outcome Measures

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