nravelling the biopsychosocial factors of fatigue and sleep complaints after traumatic brain injury

Completed

Conditions: Brain contusion
Traumatic brain injury
10042258

Registration Number: NL-OMON50267

Lead Sponsor: niversiteit Maastricht

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 137

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).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The development of subjective sleep and fatigue complaints following TBI and<br /><br>possible underlying biological (pain, brain damage), psychological (emotional<br /><br>state) and social (support family, participation) factors. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The development of objectively measured sleep-wake disturbances and fatigue<br /><br>following TBI and possible underlying biological (pain, brain damage),<br /><br>psychological (emotional state) and social (support family, participation)<br /><br>factors. </p><br>