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

NCT03119207 | Completed

• 2 other identifiers: 1112009428P20NR014126
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

Specific Aims:

1. 1.Quantify baseline patient room disruptions in the medical ICU during the proposed nocturnal Naptime .
2. 2.Obtain baseline light and noise levels in selected medical ICU study rooms.
3. 3.Obtain baseline activity level levels in selected medical ICU study rooms.
4. 4.Assess baseline information regarding nursing experience, prior training / beliefs regarding sleep promotion in the medical ICU
5. 5.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.
6. 6.Examine the associations between Naptime provision and patient sleep quality.

Conditions

Sleep

Keywords

ICU

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• RCSQ score

  Day 1-3 following study enrollment

Study Arms (3)

Naptime Participants

EXPERIMENTAL

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

Control Participants

NO INTERVENTION

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.

Baseline Participants

NO INTERVENTION

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.

Interventions

Naptime Protocol BEHAVIORAL

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

Naptime Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Officials

• Melissa Knauert, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 18, 2017
• Study Start: November 4, 2012
• Primary Completion: June 22, 2014
• Study Completion: June 22, 2014
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share