Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03119207
Enrollment
85
Registered
2017-04-18
Start date
2012-11-04
Completion date
2014-06-22
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

ICU

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.

Interventions

BEHAVIORALNaptime Protocol

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

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sound LevelDay 1-3 following study enrollmentSound 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 LevelDay 1-3 following study enrollmentLight 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.
Number of Room EntrancesDay 1-3 following study enrollmentThe 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.
Length of Room EntrancesDay 1-3 following study enrollmentThe 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 EntrancesDay 1-3 following study enrollmentThe 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

MeasureTime frameDescription
RCSQ scoreDay 1-3 following study enrollmentThe Richards Campbell Sleep Questionnaire will be administered to all patients and their primary overnight nurses to evaluate sleep quality.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026