- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02978053
Light Treatment to Shift-working Nurses
October 1, 2019 updated by: Bjorn Bjorvatn, University of Bergen
The Effects of Bright Light on Adaptation to Night Work Among Nurses
This project examines 1) the effects of appropriately timed bright light on adaptation (in terms of sleep and sleepiness) to three consecutive night shifts; and 2) the effects of such bright light on re-adaptation (in terms of sleep and sleepiness) to a day-oriented schedule after the night shift period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Shift workers frequently experience sleepiness during night shifts, which may have consequences for performance.
Sleep duration is often shortened after a night shift.
Properly timed bright light treatment is efficient in delaying the circadian rhythm and can enhance alertness, increase performance and prolong sleep after night shifts.
There is a lack of studies on light treatment to rotating shift workers.
This study is a randomized controlled crossover trial evaluating the effect of bright light treatment on sleep and sleepiness in rotating shift workers with three consecutive night shifts.
The aim is to evaluate whether bright light treatment improves adaptation to three consecutive night shifts (reduces sleepiness during night shifts and improves sleep after night shifts), as well as whether such treatment affects re-adaptation to a day-oriented schedule after the night shift period.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hordaland
-
Bergen, Hordaland, Norway, 5018
- University of Bergen
-
-
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
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A rotating shift work schedule involving three days without night shifts, followed by three consecutive night shifts, followed by three days without night shifts
- Problems with sleepiness during night shifts
Exclusion Criteria:
- Pregnancy
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: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bright light
10 000 lux
|
Bright light for 30 minutes during night shifts (between 2 AM and 3 AM the first night, between 3 AM and 4 AM the second night, between 4 AM and 5 AM the third night).
|
|
Placebo Comparator: Red light
400 lux
|
Red light for 30 minutes during night shifts (between 2 AM and 3 AM the first night, between 3 AM and 4 AM the second night, between 4 AM and 5 AM the third night).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleepiness during the night shifts
Time Frame: 3 days
|
Self-reported using the Karolinska Sleepiness Scale (KSS)
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychomotor vigilance during night shifts
Time Frame: 3 days
|
Objective data from a 5 min computer based psychomotor vigilance test (PC-PVT) taken once during each night shift
|
3 days
|
|
Sleep after the night shifts
Time Frame: 3 days
|
Self-reported using a sleep diary; objective data from actigraphs
|
3 days
|
|
Sleepiness during the days after the night shift period
Time Frame: 3 days
|
Self-reported using the Karolinska Sleepiness Scale (KSS)
|
3 days
|
|
Sleep during the days after the night shift period
Time Frame: 3 days
|
Self-reported using a sleep diary; objective data from actigraphs
|
3 days
|
|
Functioning on each shift, and shift period in total, compared to under normal conditions
Time Frame: 6 days
|
Self-reported perception of effect of intervention
|
6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bjørn Bjorvatn, MD, PhD, University of Bergen
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)
November 1, 2016
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
November 25, 2016
First Submitted That Met QC Criteria
November 25, 2016
First Posted (Estimate)
November 30, 2016
Study Record Updates
Last Update Posted (Actual)
October 2, 2019
Last Update Submitted That Met QC Criteria
October 1, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UiB112016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Shift-Work Sleep Disorder
-
Henry Ford Health SystemRecruitingShift Work Sleep DisorderUnited States
-
VA Palo Alto Health Care SystemMerck Sharp & Dohme LLC; Stanford UniversityCompletedSleep Disorder, Shift-WorkUnited States
-
University of BergenCompleted
-
University of BergenActive, not recruiting
-
Henry Ford Health SystemCephalonCompletedShift Work Sleep DisorderUnited States
-
CephalonCompletedChronic Shift Work Sleep DisorderUnited States
-
University of OxfordRecruitingShift-work DisorderUnited Kingdom
-
Centre Hospitalier Universitaire de NiceNot yet recruiting
-
Brigham and Women's HospitalNational Institute on Aging (NIA); University of Massachusetts, LowellTerminatedShift-Work Sleep Disorder | Shift-Work Related Sleep DisturbanceUnited States
Clinical Trials on Bright light
-
China Medical University HospitalCompletedPhotobiomodulationTaiwan
-
University of ArizonaU.S. Army Medical Research Acquisition ActivityCompletedConcussion, Mild | Sleep Problems | Post-Concussion SymptomsUnited States
-
University of ArizonaU.S. Army Medical Research Acquisition ActivityCompletedConcussion, Mild | Sleep Problems | Post-Concussion SymptomsUnited States
-
Yale UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedCircadian Rhythm Sleep Disorder, UnspecifiedUnited States
-
Radford UniversityCommonwealth Care of Roanoke, Inc.; Virginia Center on Aging (ARDRAF)Completed
-
Northwestern UniversityRush UniversityCompletedPreDiabetes | Circadian DysregulationUnited States
-
Shanghai Zhongshan HospitalFudan University; Shanghai Mental Health Center, Jingan District; Shanghai Mental...Unknown
-
University of ArizonaU.S. Army Medical Research Acquisition ActivityCompleted
-
University of WashingtonIcahn School of Medicine at Mount Sinai; University of North Texas Health Science...CompletedSleep | Traumatic Brain Injury | TBIUnited States
-
University of PittsburghCompleted