Examining the development of fatigue and sleep complaints following moderate to severe TBI and exploring the underlying causes within a biopsychosocial model. We hypothesize that biological factors are associated with sleep complaints and fatigue in…
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The development of subjective sleep and fatigue complaints following TBI and
possible underlying biological (pain, brain damage), psychological (emotional
state) and social (support family, participation) factors.
Secondary outcome
The development of objectively measured sleep-wake disturbances and fatigue
following TBI and possible underlying biological (pain, brain damage),
psychological (emotional state) and social (support family, participation)
factors.
Background summary
Moderate to severe traumatic brain injury (TBI) can drastically impact the
quality of life (QOL) and participation of the patient and their family and
friends. It is often referred to as a silent epidemic due to lack of public and
healthcare awareness. Sleep complaints and fatigue are common symptoms and play
a significant role in the disease process and are associated with additional
symptoms such as depression, anxiety, and pain. Patients experience sleep-wake
disturbances (SWD) and fatigue as one of the most distressing symptoms and
subsequently these symptoms influence the recovery trajectory. The etiology is
still debated, uncertain and no efficacious treatment has been established. The
development over time and the underlying causes of persistent fatigue and sleep
complaints still need to be examined for the moderate to severe TBI spectrum.
This study will therefore examine the development of sleep and fatigue
following moderate to severe TBI and the role biopsychosocial factors play in
persistent sleep complaints and fatigue over time. Identifying underlying
causes of persistent sleep complaints and fatigue post-TBI can give direction
and rationale for the development of interventions and treatment of these
symptoms.
Study objective
Examining the development of fatigue and sleep complaints following moderate to
severe TBI and exploring the underlying causes within a biopsychosocial model.
We hypothesize that biological factors are associated with sleep complaints and
fatigue in the first 3-6 months following injury and that psychological factors
are associated with sleep complaints and fatigue over time starting at 6
months. Social factors will start playing a role later in the disease process
and are expected to be associated with sleep complaints and fatigue between 12
and 18 months.
Study design
Longitudinal multicentre observational cohort study with 4 measurement points
(3, 6, 12 and 18 months post injury). In addition, there is screening visit
within the first 6 weeks, if the patient meets the in- and exclusion criteria
the study will continue and demographics and pre-injury characteristic will be
determined. This screening visit can take place at the home of the participant
or if preferred by the participant at Maastricht University or the
participating hospital. The 4 measurement points will consist of subjective
questionnaires and cognitive tasks and take place at Maastricht University or
one of the participating hospitals. In the week prior to these visits the
participants will wear a watch-like device (actigraph) and fill in sleep
diaries every morning for 1 week. During this week participants can continue
normal routines in the natural environment.
Study burden and risks
The burden and risks associated with participation are considered to be
limited. The burden of this study consists of 5 visits and filling in a sleep
diary during 1 week for four times in the course of 18 months. There is no
physical or physiological discomfort associated with participation. Iatrogenic
risks of this study are considered negligible due to its observational nature.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- First moderate-severe, closed-head injury TBI
- Age 21 - 80
- Fluent in Dutch
- Informed consent (IC)
Exclusion criteria
- Prior moderate-severe TBI diagnosed by a neurologist
- Mild concussion in the last half year
- Pre-existing neurological disorder or a brain injury with an etiology other
than trauma: Stroke, idiopathic epilepsy, brain tumor, multiple sclerosis,
Huntington*s disease, Parkinson*s disease, meningitis, encephalitis
- History of drug and/or alcohol abuse abuse (addiction or long term abuse,
does not include a night of binge drinking/alcohol intoxication during the
accident)
- Sleep disorders prior to TBI (diagnosed or treated for a sleep disorders)
- Chronic fatigue syndrome prior to TBI
- Sleep-wake patterns disturbances or fatigue due to another medical condition
than TBI
- Mental disorders for which treatment was necessary (i.e. medication or
psychological/psychiatric treatments; post-injury depression, anxiety disorders
no exclusion)
- Pregnancy
- Lacking the ability to complete questionnaires based on clinical judgment
(aphasia, severe cognitive impairment).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60332.068.17 |