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| ID | Type | Description | Link |
|---|---|---|---|
| P20NR014126 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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Specific Aims:
Quantify baseline patient room disruptions in the medical ICU during the proposed nocturnal Naptime .
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
Examine the associations between Naptime provision and patient sleep quality.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naptime Protocol | Behavioral | Between midnight and 4:00 every attempt will be made to limit staff entrance into the patient room. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| RCSQ score | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Knauert, MD, PhD | Yale University | Principal Investigator |
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| Day 1-3 following study enrollment |