Modified Environment for Agitation in Patients With TBI (ABS)

May 4, 2018 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midt
      • Aarhus, Region Midt, Denmark, 8000
        • Leanne Langhorn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Intervention: Circadian lighting, systematic information, music, foreclosure of the individual patient
Behavioral: Multifactorial circadian concept
Circadian light, systematic information, music, individual foreclosure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Agitation on Agitated Behaviour Scale (ABS)
Time Frame: One year
One year
Functional abilities on the Early Functional Abilities Scale (EFA)
Time Frame: One year
One year
Functional abilities on the Glasgow Outcome Extend Scale
Time Frame: 12 month after admission
12 month after admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Orientation and duration of post-traumatic amnesia on the Galveston Orientation and Amnesia Scale (GOAT)
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

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

Investigators

  • Study Chair: Jens Christian H Sorensen, Professor, Aarhus University Hoapital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (ESTIMATE)

August 14, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABS project

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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