NCT02524067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 11, 2018

Status Verified

September 1, 2016

Enrollment Period

2.7 years

First QC Date

July 8, 2015

Last Update Submit

May 4, 2018

Conditions

Traumatic Brain Injury (TBI)Agitated Behaviour

Outcome Measures

Primary Outcomes (3)

  • 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 (1)

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

    One year

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Multifactorial circadian concept

Interventions

Multifactorial circadian conceptBEHAVIORAL

Circadian light, systematic information, music, individual foreclosure

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with psychiatric diagnose and not speaking danish -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leanne Langhorn

Aarhus, Region Midt, 8000, Denmark

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticPsychomotor Agitation

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesDyskinesiasNeurologic ManifestationsPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Officials

  • Jens Christian H Sorensen, Professor

    Aarhus University Hoapital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2015

First Posted

August 14, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 11, 2018

Record last verified: 2016-09

Locations

DK(1)