Shift Work ScheduleNCT04160572
Sleep Schedule Intervention Study Among Night Shift Workers
A study testing Morning sleep schedule and Evening sleep schedule in people with Shift Work Schedule, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This study will recruit 60 night shift workers with shift work disorder. They will be invited to wear actigraphy for 3 weeks. In the first week the participants will sleep at the time they used to, and their chronotype will be determined by actigraphy and Munich Chronotype Questionnaire. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Shift Work Schedule
- What is being tested?
- Morning sleep schedule and Evening sleep schedule
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Dec 2019to 27 Jul 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shift work disorder
Who cannot join
- Neuromuscular disorder
- Taking hypnotics
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
This study will recruit 60 night shift workers with shift work disorder. They will be invited to wear actigraphy for 3 weeks. In the first week the participants will sleep at the time they used to, and their chronotype will be determined by actigraphy and Munich Chronotype Questionnaire. In the second week the participants will be randomly assigned to morning sleep or evening sleep time, and will change to the other in the third week. We will compare sleepiness, sleep quality, daytime vigilance score changes using mixed method ANOVA. We will also examine the interaction effect of chronotype and sleep schedule on sleep-related outcome.
- Conditions
- Shift Work Schedule
- Being tested
- Morning sleep schedule, Evening sleep schedule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning sleep scheduleBehavioural
sleep right after night shifts
Evening sleep scheduleBehavioural
sleep before night shifts
| Study group | Role | What they receive |
|---|---|---|
| Morning-evening sleep schedule | Experimental | Not described Receives: Behavioral: Morning sleep schedule; Behavioral: Evening sleep schedule |
| Evening-morning sleep schedule | Active comparator | Not described Receives: Behavioral: Morning sleep schedule; Behavioral: Evening sleep schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Pittsburgh sleep quality index (PSQI), range from 0 (better) to 21 (worse)
Measured: Change from baseline score at the second and third week.
Secondary outcomes (2)
Daytime sleepiness
Karolinska Sleepiness Scale (KSS), range from 1 (better) to 9 (worse)
Measured: Change from baseline score at the start and end of each night shift.
Alertness
Psychomotor vigilance test (PVT), reaction time (longer the worse) and lapses (larger the worse)
Measured: Change from baseline score at the start and end of each night shift.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start17 Dec 2019
- Primary completion23 Dec 2020
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shift Work ScheduleStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Ju Cheng, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160572
- Sponsor's protocol ID
- CMUH108-REC3-097
- Status last verified
- Jul 2021
- First submitted
- 8 Nov 2019
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng WJ, Hang LW, Kubo T, Vanttola P, Huang SC. Impact of sleep timing on attention, sleepiness, and sleep quality among real-life night shift workers with shift work disorder: a cross-over clinical trial. Sleep. 2022 Apr 11;45(4):zsac034. doi: 10.1093/sleep/zsac034.
PubMed 35148396
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Schedule Intervention Study Among Night Shift Workers
- ClinicalTrials.gov ID
- NCT04160572
- Acronym / sponsor ID
- CMUH108-REC3-097
- Conditions
- Shift Work Schedule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 13 Nov 2019 (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.
This study will recruit 60 night shift workers with shift work disorder. They will be invited to wear actigraphy for 3 weeks. In the first week the participants will sleep at the time they used to, and their chronotype will be determined by actigraphy and Munich Chronotype Questionnaire. In the second week the participants will be randomly assigned to morning sleep or evening sleep time, and will change to the other in the third week. We will compare sleepiness, sleep quality, daytime vigilance score changes using mixed method ANOVA. We will also examine the interaction effect of chronotype and sleep schedule on sleep-related outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning-evening sleep schedule | Experimental | Behavioral: Morning sleep schedule, Behavioral: Evening sleep schedule |
| Evening-morning sleep schedule | Active comparator | Behavioral: Morning sleep schedule, Behavioral: Evening sleep schedule |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Shift work disorder
Key exclusion criteria (3 listed)
- Neuromuscular disorder
- Taking hypnotics
- 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 |
|---|---|---|
| Morning sleep schedulesleep right after night shifts | Behavioural | Evening-morning sleep schedule, Morning-evening sleep schedule |
| Evening sleep schedulesleep before night shifts | Behavioural | Evening-morning sleep schedule, Morning-evening sleep schedule |
Primary outcome
Sleep quality
Time frame: Change from baseline score at the second and third week.
Pittsburgh sleep quality index (PSQI), range from 0 (better) to 21 (worse)
2 secondary outcomes
Daytime sleepiness
Time frame: Change from baseline score at the start and end of each night shift.
Alertness
Time frame: Change from baseline score at the start and end of each night shift.
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 30 Jul 2021.
- Derived from this study: PubMed 35148396Cheng WJ, Hang LW, Kubo T, Vanttola P, Huang SC. Impact of sleep timing on attention, sleepiness, and sleep quality among real-life night shift workers with shift work disorder: a cross-over clinical trial. Sleep. 2022 Apr 11;45(4):zsac034. doi: 10.1093/sleep/zsac034.
- 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.
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 Morning sleep schedule and Evening sleep schedule in people with Shift Work Schedule, run by China Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 3 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 30 Jul 2021. 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 Taiwan. 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?
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?
Sleep quality (time frame: Change from baseline score at the second and third week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04160572, which also lists 1 linked publication.
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 30 Jul 2021.