Shift-Work Sleep DisorderNCT02978053
Light Treatment to Shift-working Nurses
A study testing Bright light and Red light in people with Shift-Work Sleep Disorder, run by University of Bergen at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Sleep Disorder
- What is being tested?
- Bright light and Red light
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Shift-Work Sleep Disorder
- Being tested
- Bright light, Red light
- Keywords
- Bright light, Sleepiness, Sleep, Psychomotor vigilance
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright lightBehavioural
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).
Red lightBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Bright light | Experimental | 10 000 lux Receives: Behavioral: Bright light |
| Red light | Placebo comparator | 400 lux Receives: Behavioral: Red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleepiness during the night shifts
Self-reported using the Karolinska Sleepiness Scale (KSS)
Measured: 3 days
Secondary outcomes (5)
Psychomotor vigilance during night shifts
Objective data from a 5 min computer based psychomotor vigilance test (PC-PVT) taken once during each night shift
Measured: 3 days
Sleep after the night shifts
Self-reported using a sleep diary; objective data from actigraphs
Measured: 3 days
Sleepiness during the days after the night shift period
Self-reported using the Karolinska Sleepiness Scale (KSS)
Measured: 3 days
Sleep during the days after the night shift period
Self-reported using a sleep diary; objective data from actigraphs
Measured: 3 days
Functioning on each shift, and shift period in total, compared to under normal conditions
Self-reported perception of effect of intervention
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-Work Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjorn Bjorvatn, University of Bergen
- Investigators
- Bjørn Bjorvatn, MD, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978053
- Sponsor's protocol ID
- UiB112016
- Status last verified
- Oct 2019
- First submitted
- 25 Nov 2016
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bright Light on Adaptation to Night Work Among Nurses
- ClinicalTrials.gov ID
- NCT02978053
- Acronym / sponsor ID
- UiB112016
- Conditions
- Shift-Work Sleep Disorder
- Keywords
- Bright light, Sleepiness, Sleep, Psychomotor vigilance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright light | Experimental | Behavioral: Bright light10 000 lux |
| Red light | Placebo comparator | Behavioral: Red light400 lux |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright lightBright 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). | Behavioural | Bright light |
| Red lightRed 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). | Behavioural | Red light |
Primary outcome
Sleepiness during the night shifts
Time frame: 3 days
Self-reported using the Karolinska Sleepiness Scale (KSS)
5 secondary outcomes
Psychomotor vigilance during night shifts
Time frame: 3 days
Sleep after the night shifts
Time frame: 3 days
Sleepiness during the days after the night shift period
Time frame: 3 days
Sleep during the days after the night shift period
Time frame: 3 days
Functioning on each shift, and shift period in total, compared to under normal conditions
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjørn Bjorvatn, MD, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright light and Red light in people with Shift-Work Sleep Disorder, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleepiness during the night shifts (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019; AzTrials last refreshed its copy on 27 Oct 2026.