Shift-work DisorderNCT06440434
Effects of Morningness on Night Split Shift Performance
A study testing Time of night shift in people with Shift-work Disorder, run by University of Bergen at 1 site in Norway.
Trial summary
The goal is to investigate if the morningness-eveningness dimension mediates sleep and function on spilt night shifts (midnight-4am and 4am-8am). Does those with high score of morningness function relatively better on the last compared to the first split shift? Participants will: Record their sleep from 2 days prior… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift-work Disorder
- What is being tested?
- Time of night shift
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 19 Apr 2024to 31 Dec 2024
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years old
- no incorrectable vision problems
Who cannot join
- regular use of sleep medication
Trial locations and contacts
1 site in 1 country.
About this study
The goal is to investigate if the morningness-eveningness dimension mediates sleep and function on spilt night shifts (midnight-4am and 4am-8am).
Does those with high score of morningness function relatively better on the last compared to the first split shift?
Participants will:
Record their sleep from 2 days prior to 2 days following the split shift During the shifts complete questionnaires assessing mood, sleepiness and perceived performance as well as complete cognitive tests: Psychomotor vigilance test, digit symbol substitution test, working memory scanning test, reversal learning test, and visual search test
Read the detailed description
A sample of 28 students will be recruited and exposed to two conditions in a randomized, controlled, crossover study. They will be assessed with subjective (sleep diary) and objective sleep measures (sleep radar) for 2 days before the night shift, during the night shift and 2 days following the night shift. The simulated night shifts will last from midnight to 8am and will be divided into two halves (midnight-4am and 4am-8am), denoted as split-shift, and for each participant separated by at least 1 week. Based on the Horne-Östberg Morningness-Eveningness Questionnaire (median spilt) two groups are created, from which participants will be randomized to the two orders of the spilt-shift.
Each hour on each shift the participants will complete: Positive and Negative Affect Schedule (PANAS), Karolinska Sleepiness Scale, perceived performance and the following cognitive tests: Psychomotor vigilance test, Digit symbol substitution test, Working memory scanning test, Reversal learning test, and Visual search test.
Data will be analyzed with linear mixed models with three fixed factors: Group (low vs. high morningness), shift (midnight-4am vs. 4am-8am), and hour and one random factor (participant).
- Conditions
- Shift-work Disorder
- Being tested
- Time of night shift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time of night shiftBehavioural
Early vs. late night split night shift
| Study group | Role | What they receive |
|---|---|---|
| Early night shift (midnight-4am) | Active comparator | Not described Receives: Behavioral: Time of night shift |
| Late night shift (4am - 8am) | Active comparator | Not described Receives: Behavioral: Time of night shift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time
Total sleep (sleep diary and radar). Higher values indicates more sleep
Measured: Total sleep time between 6pm day before shift start to 6pm the day the shift end for both early night shift (midnight-04am) and late night shift (04am-08am)
Psychomotor Vigilance Test (PVT)
Reaction time (mean 1/RT) and number of lapses (RTs≥500 ms). For mean 1/RT higher values are associated with best performance, on lapses higher values are associated with worst performance
Measured: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Karolinska Sleepiness Scale (KSS)
Assessment of state sleepiness, range 1-9 (higher scores indicate worse state)
Measured: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Secondary outcomes (7)
Sleep efficiency (percentage of time in bed one sleeps)
Sleep efficiency (diary and radar). Range from 0-100%. Higher scores indicate best state
Measured: Between 6pm day before shift start to 6pm the day the shift end for both early night shift (midnight-04am) and late night shift (04am-08am)
Positive and Negative Affect Schedule (PANAS)
Assessment of mood/affect. Range 10-50. On positive mood subscale higher scores indicate best state, on negative mood state, higher scores indicate worst state
Measured: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Self-rated performance
Self-rated performance on cognitive tests. Range 1-10. Higher scores indicate best performance rating
Measured: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Digital Symbol Substitution Test
Test where one match symbols to numbers as fast as possible. Range 0-100. Higher scores indicate best performance
Measured: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Working Memory Scanning Test (probed recall)
Test presenting list of words. Then words are presented and subjects decide if word was present or not in list presented. The accuracy and RTs for positive trials (where probe was present in list) will be used as dependent variables. Higher accuracy and lower reaction time are associated with best performance
Measured: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Reversal Learning Test
Test measuring the ability to differentiating between "go-stimuli" and "no-go stimuli" before and after reversal of go and no-go stimuli. Discriminability (hit rate/false alarm rate) and response bias before and after reversal are recorded. Higher discriminability indicates better performance, higher response bias indicate worse performance
Measured: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Visual Search Test
Multiple objects are presented, and from among them a target is identified. The task of the subject is finding the target. Outcomes are reaction time (RT) and accuracy. Lower reaction times and higher accuracy are associated with best performance
Measured: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start19 Apr 2024
- Primary completion20 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-work 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A 2 (midnight-4am vs.4am-8am) within factor x 2 (below vs. above median on morningness) between factor experimental design
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ståle Pallesen, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440434
- Sponsor's protocol ID
- M3447
- Status last verified
- Jun 2024
- First submitted
- 14 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If legel in terms of data protection regulations data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Morningness on Night Split Shift Performance
- ClinicalTrials.gov ID
- NCT06440434
- Acronym / sponsor ID
- M3447
- Conditions
- Shift-work Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Jun 2024 (actual)
- 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.
The goal is to investigate if the morningness-eveningness dimension mediates sleep and function on spilt night shifts (midnight-4am and 4am-8am).
Does those with high score of morningness function relatively better on the last compared to the first split shift?
Participants will:
Record their sleep from 2 days prior to 2 days following the split shift During the shifts complete questionnaires assessing mood, sleepiness and perceived performance as well as complete cognitive tests: Psychomotor vigilance test, digit symbol substitution test, working memory scanning test, reversal learning test, and visual search test
Detailed description
A sample of 28 students will be recruited and exposed to two conditions in a randomized, controlled, crossover study. They will be assessed with subjective (sleep diary) and objective sleep measures (sleep radar) for 2 days before the night shift, during the night shift and 2 days following the night shift. The simulated night shifts will last from midnight to 8am and will be divided into two halves (midnight-4am and 4am-8am), denoted as split-shift, and for each participant separated by at least 1 week. Based on the Horne-Östberg Morningness-Eveningness Questionnaire (median spilt) two groups are created, from which participants will be randomized to the two orders of the spilt-shift.
Each hour on each shift the participants will complete: Positive and Negative Affect Schedule (PANAS), Karolinska Sleepiness Scale, perceived performance and the following cognitive tests: Psychomotor vigilance test, Digit symbol substitution test, Working memory scanning test, Reversal learning test, and Visual search test.
Data will be analyzed with linear mixed models with three fixed factors: Group (low vs. high morningness), shift (midnight-4am vs. 4am-8am), and hour and one random factor (participant).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 2 (midnight-4am vs.4am-8am) within factor x 2 (below vs. above median on morningness) between factor experimental design
| Arm | Type | Receives |
|---|---|---|
| Early night shift (midnight-4am) | Active comparator | Behavioral: Time of night shift |
| Late night shift (4am - 8am) | Active comparator | Behavioral: Time of night shift |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-40 years old
- no incorrectable vision problems
Key exclusion criteria (1 listed)
- regular use of sleep medication
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 |
|---|---|---|
| Time of night shiftEarly vs. late night split night shift | Behavioural | Early night shift (midnight-4am), Late night shift (4am - 8am) |
Primary outcome
Total sleep time
Time frame: Total sleep time between 6pm day before shift start to 6pm the day the shift end for both early night shift (midnight-04am) and late night shift (04am-08am)
Total sleep (sleep diary and radar). Higher values indicates more sleep
Psychomotor Vigilance Test (PVT)
Time frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Reaction time (mean 1/RT) and number of lapses (RTs≥500 ms). For mean 1/RT higher values are associated with best performance, on lapses higher values are associated with worst performance
Karolinska Sleepiness Scale (KSS)
Time frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Assessment of state sleepiness, range 1-9 (higher scores indicate worse state)
7 secondary outcomes
Sleep efficiency (percentage of time in bed one sleeps)
Time frame: Between 6pm day before shift start to 6pm the day the shift end for both early night shift (midnight-04am) and late night shift (04am-08am)
Positive and Negative Affect Schedule (PANAS)
Time frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Self-rated performance
Time frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Digital Symbol Substitution Test
Time frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Working Memory Scanning Test (probed recall)
Time frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Reversal Learning Test
Time frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Visual Search Test
Time frame: Hourly during shifts (0:15am, 1:15am, 2:15am and 3:15am on early night shift; 4:15am, 5:15am, 6:15am and 7:15 am on late night shift)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Undecided. If legel in terms of data protection regulations data will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time of night shift in people with Shift-work 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. 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. 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?
Results are not available in the source record.
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?
Total sleep time (time frame: Total sleep time between 6pm day before shift start to 6pm the day the shift end for both early night shift (midnight-04am) and late night shift (04am-08am)). The study lists 3 primary outcomes in all. 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 13 Jun 2024.