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

April 17, 2017 updated by: Yale University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1-3 following study enrollment
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.
Day 1-3 following study enrollment
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.
Day 1-3 following study enrollment
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.
Day 1-3 following study enrollment
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.
Day 1-3 following study enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Day 1-3 following study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1112009428
  • P20NR014126 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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