The main objective of the proposed study is to investigate the effect of ctVNS as a means to counteract the effects of SD on cognitive performance during and after SD. This will be tested using both well-controlled, established cognitive desktop…
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- Other condition
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Health condition
menselijk presteren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cognitive performance on the cognitive task battery (e.g., reaction time, false
alarms, lapses)
Secondary outcome
- VR test, including the percentage of decisions properly made as measured
with a checklist for video-analysis. Quality of performance is also graded by
instructors who are present during the VR test.
- Sleepiness levels after each cognitive performance test
- Mood ratings (pre- and post tests)
- Positive- and Negative affect ratings (pre- and post tests)
- Mental effort ratings after each cognitive performance test
- Symptoms of motion sickness after the VR test
Background summary
Sleep deprivation (SD) significantly impacts cognitive functioning and
alertness, causing a decrease in performance. For military operators, (partial)
SD is often unavoidable yet potentially endangers their performance such as
maintaining alertness or making high impact decisions. A promising method to
mitigate SD-induced cognitive performance impairment is transcutaneous
peripheral nerve stimulation (tPNS). This method involves applying a small
electrical current non-invasively to the cervical branch of the vagus nerve
(e.g., in the neck; ctVNS) with a medically approved device which is normally
used for treatment of cluster headaches at home. Although studies on the effect
of ctVNS on performance are scarce, initial results are very promising showing
ctVNS increasing arousal, attention, and mood, but also counteracting feelings
of fatigue. Here we propose to test whether ctVNS can (partially) restore
cognitive performance under SD in lab settings as well as in the field.
Study objective
The main objective of the proposed study is to investigate the effect of ctVNS
as a means to counteract the effects of SD on cognitive performance during and
after SD. This will be tested using both well-controlled, established cognitive
desktop tests, and a Virtual Reality (VR) scenario-based test which aims to
more closely resemble the cognitive challenges encountered by dismounted
soldiers in the field.
Study design
The study design will be a single-blind, sham-controlled, between-subjects
intervention study with two groups of 20 participants. On the morning of day 1,
both groups will perform a baseline test consisting of the desktop cognitive
tests and the VR test. In the evening, the experimental group will receive
ctVNS, whereas a control group will be treated with sham stimulation. Then, all
participants will undergo one night of total SD. The desktop and VR tests are
performed again on the morning of day 2 as a post-night test. To track effects
of SD and ctVNS, the desktop tests are also performed every 3 hours during the
night between day 1 and 2.
Intervention
Both groups will undergo one night of SD, with one group receiving ctVNS and
the second group receiving sham stimulation. Electrical stimulation at 25 Hz is
applied twice for 2 minutes in the neck using a handheld device (gammaCore®
developed by electroCore®, FDA-approved and CE-marked to treat cluster
headaches and treatment-resistant migraines at home), in the evening before SD
occurs.
Study burden and risks
Participants will be invited for a single session of up to 36 hours, during
which they are asked to participate in a number of activities. There are small
burden and risks associated with participation, and there is no risk for any
serious (adverse) event. The burden consists of the following activities:
- Sleep deprivation: Participants will be kept awake all night. After sleep
deprivation they will not be able to drive home safely, they will therefore be
escorted home. Participants may experience increased fatigue the day after the
experiment.
- Peripheral nerve stimulation: Stimulation will be done with a medically
approved device (for at-home use) that applies a small current to the neck,
targeting a branch of the vagus cranial nerve. Stimulation will be applied
twice for 2 minutes, once on the left and once on the right side of the neck,
with a 2 minute break in between. Some mild discomfort may occur locally, which
stops when stimulation is stopped. Single session stimulation is associated
with minimal side-effects, and use of the device is considered safe in healthy
individuals.
- Behavioural testing: Throughout the session participants will be asked to
participate in several cognitive tasks which are performed on a laptop. Each
task takes 10-20 mins and tests different cognitive functions such as attention
and memory.
- Virtual Reality test: After sleep deprivation participants will perform
typical Special Operation Forces (SOF) tasks on foot in a VR environment.
Virtual Reality can sometimes induce cyber-sickness, which is associated with
feelings of dizziness, nausea, headache, and feeling warm. These symptoms start
to improve as soon as the VR headset is taken off. To prevent cyber-sickness we
will limit the amount of time in the VR and introduce breaks.
Benefits:
ctVNS is indicated in adults for the treatment of cluster headaches and
migraines, with improvement of symptoms found after stimulation. ctVNS is a
promising method for military applications, i.e. to counteract the decrease in
cognitive performance in a military setting where maintaining wakefulness is
necessary, and has the potential to support learning and memory, which may lead
to improved performance in the field. On the day of stimulation participants
may experience increased wakefulness and improved mood.
Kampweg 55
Soesterberg 3769DE
NL
Kampweg 55
Soesterberg 3769DE
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. The potential subject 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 have computer skills.
4. All subjects declare to be in good health, and declare not to have any
chronic diseases.
5. Subjects must be able to communicate, participate, and comply with the
requirements of the entire study.
6. 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 which may
confound the test results.
7. No signs of flue or viral infection in the last 5 days before the start.
8. Participant is active military personnel
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Pregnancy
2. Atherosclerosis
3. Other cardiovascular health issues
4. Epilepsy and a history of psychiatric illness (including sleeping
disorders).
5. Having an active implantable (metallic) device.
6. Using another device at the same time of testing or any portable electronic
device (e.g., mobile phone).
7. Used alcohol the day before the start of a test day.
8. Used drugs in the last 3 months.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL84403.028.23 |