Modified Environment for Agitation in Patients With TBI

NCT ID: NCT02524067

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Brain Injury (TBI) Agitated Behaviour

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Intervention: Circadian lighting, systematic information, music, foreclosure of the individual patient

Group Type EXPERIMENTAL

Multifactorial circadian concept

Intervention Type BEHAVIORAL

Circadian light, systematic information, music, individual foreclosure

Interventions

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Multifactorial circadian concept

Circadian light, systematic information, music, individual foreclosure

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Regionshospitalet Hammel Neurocenter

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Christian H Sorensen, Professor

Role: STUDY_CHAIR

Aarhus University Hoapital

Locations

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Leanne Langhorn

Aarhus, Region Midt, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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ABS project

Identifier Type: -

Identifier Source: org_study_id

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