Clinical trial NCT03119207: Creating Naptime: An Overnight, Non-Pharmacologic Intensive Care Unit Sleep Promotion Protocol
Official title: Creating Naptime: An Overnight, Non-Pharmacologic Intensive Care Unit Sleep Promotion Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: ICU
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-04-18
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Sound Level
timeFrame: Day 1-3 following study enrollment
measure: Light Level
timeFrame: Day 1-3 following study enrollment
measure: Number of Room Entrances
timeFrame: Day 1-3 following study enrollment
measure: Length of Room Entrances
timeFrame: Day 1-3 following study enrollment
measure: Length of Rest Periods between Room Entrances
timeFrame: Day 1-3 following study enrollment
Secondary outcomes:
measure: RCSQ score
timeFrame: Day 1-3 following study enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Melissa Knauert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: