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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119207
• Other study ID #: 1112009428
• Secondary ID: P20NR014126
• Status: Completed
• Phase: N/A
• First received: April 12, 2017
• Last updated: April 17, 2017
• Start date: November 4, 2012
• Est. completion date: June 22, 2014

Study information

• Verified date: April 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: June 22, 2014
• Est. primary completion date: June 22, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Nursing Research (NINR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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