Modified Environment for Agitation in Patients With TBI | NCT02524067

Studies
Modified Environment for Agitation in Patients With TBI

NCT02524067

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

May 11, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Traumatic Brain Injury (TBI)
Agitated Behaviour

Interventions

Multifactorial circadian concept

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

May 2018Actual

Completion Date

May 2018Actual

First Submitted Date

Jul 8, 2015

First Submission Date that Met QC Criteria

Aug 12, 2015

First Posted Date

Aug 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2018

Last Update Posted Date

May 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University of AarhusOTHER

Collaborators

Name	Class
Aarhus University Hospital	OTHER
Regionshospitalet Hammel Neurocenter	OTHER
Rigshospitalet, Denmark	OTHER
Glostrup University Hospital, Copenhagen

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Intervention: Circadian lighting, systematic information, music, foreclosure of the individual patient	Behavioral: Multifactorial circadian concept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multifactorial circadian concept	Behavioral	Circadian light, systematic information, music, individual foreclosure	Intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Christian H Sorensen, Professor	Aarhus University Hoapital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leanne Langhorn		Aarhus	Region Midt	8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D011595	Psychomotor Agitation

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided