NCT03331822

Brief Summary

In the majority of intensive care units, nurses work 12 hour shifts that consist of days and nights. Shift work outside of 6am-6pm has been reported to cause fatigue, induce sleep disorders, and cause metabolic disturbances. This shift to a nocturnal 'day' rather than diurnal, can result in reduced work performance, processing errors, accidents at work, absenteeism, and reduced quality of life. More chronically, those working at night have been shown to experience higher risks of heart disease, cancer and shorter median durations of life span. Much of this elevated risk is thought to be due to altered exposure to light, the dominant environmental cue regulating our circadian rhythms. As diurnal organisms much of our biology is regulated by the solar day. Acutely, bright light exposure (i.e., sun) regulates the phase of the biological clock principally through the suppression of melatonin, which biologically mediates increased alertness and in essence, 'our daytime alertness'. During the night melatonin gradually increases and induces tiredness and ultimately sleep. This, in part, is biology behind the use of melatonin in those with sleep disturbances or to mitigate jet lag, with cross-continental or transoceanic flights. In this study, the investigators will randomize nurses in the hospital to receive either high intensity white light (3,000 lux) or standard ambient white fluorescent (\~400 lx) light for 10 hours during their night shift. This high illuminance light, rich in blue spectrum, is what diurnal creatures, like humans, are exposed to during the day. The lights may subsequently be equipped with blue filters (442 nm) to heighten the exposure to the rich blue spectrum light. Exposure will commence at the beginning of the night shift (\~7pm) and continue for 10 hours. The rationale for terminating exposure prior to shift end is to foster an onset of sleep biology. At the end of each shift, the nurses will complete the Stanford Sleepiness Scale and the Psychomotor Vigilance Task (PVT). Saliva samples will be collected for melatonin level analysis and the nurses will complete sleep diaries at home. The investigators hypothesize that exposure to high intensity lighting during night shifts will reduce fatigue and enhance alertness and computational capacity that correlates with reduced melatonin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

November 1, 2017

Last Update Submit

December 13, 2018

Conditions

Keywords

circadianlight therapyICU nurse

Outcome Measures

Primary Outcomes (2)

  • Psychomotor Vigilance Task

    This test is the standard objective measure of alertness and wakefulness. It has been employed as a marker of attention deficit in hundreds of studies to date. It is a 10 minute test in which the subjects look at a small rectangular screen and press the mouse every time a bright circle appears. The number of lapses (responses greater than 500 ms) is recorded.

    Immediately at the end of the night shift worked.

  • Stanford Sleepiness Scale

    It was developed by Hoddes et al (1973) and is a simple 7-point rating scale. The scale is well validated and has been used in over 100 clinical trials.

    Immediately at the end of the night shift worked.

Secondary Outcomes (2)

  • Consensus Sleep Diary

    Throughout the course of the study for the night immediately following the night shift worked.

  • Salivary melatonin concentration

    Immediately at teh end of the night shift worked.

Study Arms (2)

Light

EXPERIMENTAL

High illuminance ,white lights positioned at each nursing station throughout the hallway to generate a uniform exposure of approximately 1,000-3,000 lux.

Other: Bright Light

No Light

NO INTERVENTION

Ambient, standard white fluorescent environmental light will serve as control.

Interventions

high illuminance white lights positioned at each nursing station throughout the hallway to generate a uniform exposure of approximately 1,000-3,000 lux. To achieve this illuminance, a Day\*Light Classic Light will be positioned at each nursing station in the ICU hallway.

Light

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All ICU nurses working at the University of Pittsburgh Trauma ICU.

You may not qualify if:

  • Not working nights

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Matthew R. Rosengart

Pittsburgh, Pennsylvania, 15217, United States

Location

Related Publications (1)

  • Griepentrog JE, Labiner HE, Gunn SR, Rosengart MR. Bright environmental light improves the sleepiness of nightshift ICU nurses. Crit Care. 2018 Nov 13;22(1):295. doi: 10.1186/s13054-018-2233-4.

MeSH Terms

Conditions

Chronobiology Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: This is randomized crossover trial, in which each nursing subject will serve as his or her own control: i.e., matched. The subjects will be nurses from the 6FG Trauma Intensive Care Unit at UPMC Presbyterian hospital.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 1, 2017

First Posted

November 6, 2017

Study Start

October 15, 2017

Primary Completion

December 1, 2017

Study Completion

December 31, 2017

Last Updated

December 14, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations