Skip to content

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

Unravelling the biopsychosocial factors of fatigue and sleep complaints after traumatic brain injury - Sleep and fatigue following TBI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50267
Enrollment
137
Registered
2017-07-05
Start date
2017-11-27
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain contusion Traumatic brain injury

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - First moderate-severe, closed-head injury TBI - Age 21 - 80 - Fluent in Dutch - Informed consent (IC)

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)