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Completed

NCT Number: NCT02524067

Modified Environment for Agitation in Patients With TBI

This study examines the effect of an intervention consisting of dynamic circadian light and sound therapy, as well as systematic information on sleep pattern, agitated behavior and functioning level.

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Key information

Conditions

Traumatic Brain Injury (TBI) Aberrant Motor Behavior in Dementia Agitated Behaviour Behavior Behavioral Symptoms Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leanne Langhorn

Aarhus, Region Midt, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with moderate and severe Traumatic Brain Injury (TBI)
  • Diagnosed with Glasgow Coma Score (GCS) lower than 13-

Exclusion criteria

  • Patients with psychiatric diagnose and not speaking danish -

Treatment and study plan

Multifactorial circadian concept

Behavioral

Circadian light, systematic information, music, individual foreclosure

Primary outcomes

  1. Agitation on Agitated Behaviour Scale (ABS)

    Time frame: One year

  2. Functional abilities on the Early Functional Abilities Scale (EFA)

    Time frame: One year

  3. Functional abilities on the Glasgow Outcome Extend Scale

    Time frame: 12 month after admission

Secondary outcomes

  1. Orientation and duration of post-traumatic amnesia on the Galveston Orientation and Amnesia Scale (GOAT)

    Time frame: One year

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Glostrup University Hospital, Copenhagen
  • Regionshospitalet Hammel Neurocenter
  • Rigshospitalet, Denmark

Registry information

Official study title

Modified Environment for Agitation in Patients With Traumatic Brain Injury: a Controlled Multicenter

Acronym: ABS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2015
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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