The current study aims to investigate two types of sleep interventions in night shift workers: a split sleep intervention strategy and a short sleep episode (powernap, max. 20 min) during a night shift. It will assess the effects of the two…
ID
Source
Brief title
Condition
- Other condition
- Sleep disorders and disturbances
Synonym
Health condition
risicofactoren voor metabole aandoeningen, alertheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are the quantity of sleep and alertness during night
shifts.
Secondary outcome
Secondary outcomes include quality of sleep, and a set of relevant clinical
biomarkers (of metabolic health and anthropometrics). The outcomes will be
compared between intervention and control group, pre- and post-intervention.
Background summary
Night work interferes with the timing of daily activities and disturbs the
circadian rhythms of multiple physiological processes in the human body. This
is associated with detrimental health effects, such as disturbances in sleep
(shorter, less consolidated sleep), cardiometabolic disease and infection
susceptibility. Night shift work is prevalent and difficult to limit in many
job types, yet there is currently limited evidence on effective interventions
to prevent the health consequence of shift work in a real-life context.
Therefore more research on tools for the prevention of negative health effects
is warranted.
Study objective
The current study aims to investigate two types of sleep interventions in night
shift workers: a split sleep intervention strategy and a short sleep episode
(powernap, max. 20 min) during a night shift. It will assess the effects of the
two interventions on sleep, alertness and anthropometric, physiological and
clinical blood markers for metabolic health.
Study design
A non-blinded randomized controlled intervention study, consisting of a run-in
period with baseline levels, an intervention period of ~11 months, including
measurements at the start and end of the intervention with two additional
interspersed measurements, and a potential follow up 12 months after the
intervention period*.
Intervention
All participants, including those in the control arm, receive advice on general
sleep hygiene. In addition, participants in the split sleep intervention
receive advice on how to split their daytime sleep into two blocks of sleep,
before and in between consecutive night shifts. Participants in the powernap
intervention will receive advice on when and how to take a powernap.
Participants are asked to take 1 powernap of max 20 min. during each night
shift. Powernap facilities are provided by the employer.
Study burden and risks
The total burden during the study for the sleep intervention and control groups
consists of: 2-3 visits to a location of choice of a national diagnostics
laboratory for fasting blood draws (10 mL total blood per visit), and, at a
central location near the worksite, blood pressure and anthropometric
measurements. All participants will wear an actigraphy watch and fill out an
activity-diary for a duration of 7 days per period for 5-6* periods over the
course of the study. All participants will be requested 5-6* times to fill in
questionnaires. In addition, participants will complete two 5-min alertness
tests (at beginning and end of the night shift) during 10-12* night shifts,
being the first two night shifts of a set. Venipuncture for blood samples might
be experienced as uncomfortable. We expect no discomfort from wearing the
activity trackers or responding to questionnaires. These activities are a
minimal burden to the participants and with low risks. Participants will
receive general sleep hygiene advice, powernap advice and/or split sleep
advice. Based on previous findings we expect that these advices may have a
beneficial effect on the participants* health and provide valuable insight into
the effectiveness of the interventions.
Dr.Molewaterplein 40
Rotterdam 3015GD
NL
Dr.Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
• Age 18 to 60 years.
• Work at least 3 night shifts a month on average. Night shift defined as work
at least 3 hours between 0:00- and 6:00.
• Work generally at least 2 night shifts in a row
• Work >= 20 hours per week.
• History of >= 0.5 year of working night shifts prior to the study.
• Expected to remain working night shifts for >= 1 year from inclusion in the
study.
Exclusion criteria
• Taking medication that the investigator believes would interfere with the
objectives of the study. For example, sleep medication or supplements like
melatonin.
• Pregnant or having a wish to become pregnant during the study period.
• • Using powernaps during, or split-sleep strategies during or prior to, >=50%
of the night shifts (prior to the study start).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84059.078.23 |