Traumatic Brain Injury (TBI)ABSNCT02524067
Modified Environment for Agitation in Patients With TBI
A study testing Multifactorial circadian concept in people with Traumatic Brain Injury (TBI) and Agitated Behaviour, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury (TBI), Agitated Behaviour
- What is being tested?
- Multifactorial circadian concept
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate and severe Traumatic Brain Injury (TBI)
- Diagnosed with Glasgow Coma Score (GCS) lower than 13-
Who cannot join
- Patients with psychiatric diagnose and not speaking danish -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Traumatic Brain Injury (TBI), Agitated Behaviour
- Being tested
- Multifactorial circadian concept
- Medical subject headings
- Brain Injuries, Traumatic, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifactorial circadian conceptBehavioural
Circadian light, systematic information, music, individual foreclosure
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention: Circadian lighting, systematic information, music, foreclosure of the individual patient Receives: Behavioral: Multifactorial circadian concept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agitation on Agitated Behaviour Scale (ABS)
Measured: One year
Functional abilities on the Early Functional Abilities Scale (EFA)
Measured: One year
Functional abilities on the Glasgow Outcome Extend Scale
Measured: 12 month after admission
Secondary outcomes (1)
Orientation and duration of post-traumatic amnesia on the Galveston Orientation and Amnesia Scale (GOAT)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI)Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Hammel Neurocenter, Copenhagen University Hospital, Rigshospitalet, Glostrup University Hospital, Copenhagen
- Responsible party
- Sponsor
- Investigators
- Jens Christian H Sorensen, Professor, Study chair, Aarhus University Hoapital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524067
- Sponsor's protocol ID
- ABS project
- Acronym
- ABS
- Status last verified
- Sep 2016
- First submitted
- 8 Jul 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Environment for Agitation in Patients With Traumatic Brain Injury: a Controlled Multicenter
- ClinicalTrials.gov ID
- NCT02524067
- Acronym / sponsor ID
- ABS / ABS project
- Conditions
- Traumatic Brain Injury (TBI), Agitated Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Hammel Neurocenter, Copenhagen University Hospital, Rigshospitalet, Glostrup University Hospital, Copenhagen
- Study start
- Sep 2015
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Multifactorial circadian conceptIntervention: Circadian lighting, systematic information, music, foreclosure of the individual patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with moderate and severe Traumatic Brain Injury (TBI)
- Diagnosed with Glasgow Coma Score (GCS) lower than 13-
Key exclusion criteria (1 listed)
- Patients with psychiatric diagnose and not speaking danish -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifactorial circadian conceptCircadian light, systematic information, music, individual foreclosure | Behavioural | Intervention |
Primary outcome
Agitation on Agitated Behaviour Scale (ABS)
Time frame: One year
Functional abilities on the Early Functional Abilities Scale (EFA)
Time frame: One year
Functional abilities on the Glasgow Outcome Extend Scale
Time frame: 12 month after admission
1 secondary outcome
Orientation and duration of post-traumatic amnesia on the Galveston Orientation and Amnesia Scale (GOAT)
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Christian H Sorensen, Professor study chair
Aarhus University Hoapital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifactorial circadian concept in people with Traumatic Brain Injury (TBI) and Agitated Behaviour, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agitation on Agitated Behaviour Scale (ABS) (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.