The primary objective is to determine whether SD-induced cognitive decline is associated with comprehensively measured inflammatory processes as well as other possibly relevant markers. We will investigate whether these markers explain inter-…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cognitieve prestatie(verlies) door slaapdeprivatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints are inflammatory responses. These will be
assessed using capillary blood samples obtained from finger pricks.
The main primary endpoints of cognitive resilience will be defined as the
difference between cognitive performance measures before and after the night.
Cognitive resilience to SD refers to the extent to which a sleep deprived
individual maintains cognitive performance while sleep deprived.
Secondary outcome
- Cognitive performance determined based on the PVT
- HR and EDA during Psychological Synchrony
- Stanford Sleepiness Scale (SSS)
- Rating Scale of Mental Effort (RSME)
Background summary
Our understanding of why sleep deprivation (SD) affects cognitive performance,
and why it does so to such different extents in different people, is limited.
Given that SD is unavoidable in certain professions and under certain
circumstances, a better grasp on the mechanisms underlying cognitive decline
through SD, and better prediction of cognitive decline, would be valuable to
intervene and cope with negative effects of SD. A promising, recent explanation
links SD and its effects on cognitive performance to increased levels of
inflammation. In the proposed research, we focus on this possible explanation
of SD induced cognitive decline, by examining the association between decreases
in cognitive performance after a night of SD and inflammatory responses. We
take a comprehensive approach to study inflammation, including metabolic
inflammatory mediators in addition to cytokines. More broadly, it is clear that
to understand and predict cognitive effects of SD, we have to include measures
from multiple domains, which is why we also include autonomic and psychological
measures. Besides this, we will test a recently developed measure of attention
(physiological synchrony in electrodermal activity (EDA) and heart rate (HR))
can predict upcoming cognitive performance of a repeated cognitive task in the
SD participants.
Study objective
The primary objective is to determine whether SD-induced cognitive decline is
associated with comprehensively measured inflammatory processes as well as
other possibly relevant markers. We will investigate whether these markers
explain inter-individual variations in SD induced cognitive decline.
As secondary objective, we aim to determine whether intra-individual variations
in SD-induced decrease in cognitive performance over the course of the night
are associated with physiological synchrony in EDA and HR.
Study design
A mixed between- and within group, randomized controlled trial. One group will
undergo a night of sleep deprivation and the other group (control) will have a
normal night of sleep at home. Both groups will perform and undergo a number of
tests (cognitive, subjective and immunological, endocrine and
psychophysiological stress responsiveness) before and after the (sleep
deprived) night.
Intervention
N/A
Study burden and risks
There are small (SD group) to minimal (control group) burden and risks
associated with participation, and there is no risk for any serious (adverse)
event.
The burden consists of the following:
1) Having to stay awake during a single night (SD group only)
2) A trained experimenter will collect blood via finger pricks (two on day 1,
and two on day 2). This can cause a mild pain.
3) Performing cognitive tasks, questionnaires and physiology recorded through
wearables in the lab.
4) Keeping a log of activities done during the day that precedes the
sleep-deprived (or control) night.
5) Collect a fecal sample using a swab (a do-it-yourself procedure) twice at
home.
Participants are informed on all of these elements of the study, except for the
second one, in the recruitment phase.
Participants from both groups spend approximately 140 minutes in the research
institute to perform the various test; once on day 1, and once on day 2. They
also visit the research institute before for a two hour training visit.
Participants in the SD group additionally spend the night in the research
institute (from 21:00 until 8:00, immediately followed by the second 140
minutes measurement session).
Kampweg 55
Soesterberg 3769DE
NL
Kampweg 55
Soesterberg 3769DE
NL
Listed location countries
Age
Inclusion criteria
1. The potential participant has given informed and written consent and is able
to comply with all study assessments scheduled in the protocol.
2. All subjects need to be between 18 and 55 years of age.
3. All subjects has computer skills.
4. All subjects need to be in good health, and may not have any chronic
diseases.
5. BMI between 18 and 30 kg/m2.
6. No alcohol the day before the start of a test day.
7. No drugs used in the last 3 months.
8. Subjects must be able to communicate, participate, and comply with the
requirements of the entire study.
9. One week prior to starting every trial day, all subjects need to be (and
remain) in the same time zone as the CET time zone in which the research center
lies. (GMT+1, daylight savings GMT+2). This to exclude jet lags that might
confound the test results.
10. No signs of flue or viral infection in the last 10 days before the start.
Exclusion criteria
1. Smoking
2. Pregnant
3. A history of psychiatric illness; this including sleeping disorders.
4. Autoimmune disease and/or hyperactive thyroid
5. People with known heart, kidney or liver disease or neurological complaints.
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 | NL74961.028.20 |