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NCT02524067 Clinical Trial

Modified Environment for Agitation in Patients With TBI

Traumatic Brain Injury (TBI) Clinical Trial

— ABS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02524067
Other study ID # ABS project
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date May 2018

Study information
Verified date September 2016
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 -

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Multifactorial circadian concept
Circadian light, systematic information, music, individual foreclosure

Locations
Country Name City State
Denmark Leanne Langhorn Aarhus Region Midt

Sponsors (5)
Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital, Glostrup University Hospital, Copenhagen, Regionshospitalet Hammel Neurocenter, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Agitation on Agitated Behaviour Scale (ABS) One year
Primary Functional abilities on the Early Functional Abilities Scale (EFA) One year
Primary Functional abilities on the Glasgow Outcome Extend Scale 12 month after admission
Secondary Orientation and duration of post-traumatic amnesia on the Galveston Orientation and Amnesia Scale (GOAT) One year
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