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

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ClinicalTrials.gov Identifier: NCT03119207
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Yale University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Behavioral: Naptime Protocol Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Creating Naptime: An Overnight, Non-Pharmacologic Intensive Care Unit Sleep Promotion Protocol
Actual Study Start Date : November 4, 2012
Actual Primary Completion Date : June 22, 2014
Actual Study Completion Date : June 22, 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: Naptime Protocol
Between midnight and 4:00 every attempt will be made to limit staff entrance into the patient room.
No Intervention: 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.
No Intervention: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Sound Level [ Time Frame: 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.

  2. Light Level [ Time Frame: 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.

  3. Number of Room Entrances [ Time Frame: 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.

  4. Length of Room Entrances [ Time Frame: 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.

  5. Length of Rest Periods between Room Entrances [ Time Frame: 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.


Secondary Outcome Measures :
  1. RCSQ score [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119207


Sponsors and Collaborators
Yale University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Melissa Knauert, MD, PhD Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03119207    
Other Study ID Numbers: 1112009428
P20NR014126 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
ICU