Brain InjuriesNCT02565121
Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital
A study testing corticosteroids and olfactory stimulation in people with Brain Injuries and Olfaction Disorders, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The aim of the study is to see whether patients with chronic smell impairment after brain injury benefit from a treatment that consists of corticosteroids, and then olfactory training in 3 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Injuries, Olfaction Disorders
- What is being tested?
- corticosteroids and olfactory stimulation
- 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 siteNorway
- Study dates
- Jun 2013to Aug 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Registered in the TBI Database
- 18-65 years of age per 01.10. 2012
- Olfaction score by Sniffin Sticks Threshold-Discrimination-Identification (TDI) < 30 confirming dysosmia
Who cannot join
- Unable to express senses.
- Unable to follow treatment and protocol
- pregnancy
- diabetes
- tendency to infections
- hypertonia
- dyspepsia
- interfering medication (hormonal treatment, NSAIDS, antidiabetics, barbiturates, fenitoin, carbamazepin, rifampicin, cyclophosphamides)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital: Prevalence and Treatment
The aim of the study is to see whether patients with chronic smell impairment after brain injury benefit from a treatment that consists of corticosteroids, and then olfactory training in 3 months.
- Conditions
- Brain Injuries, Olfaction Disorders
- Being tested
- corticosteroids, olfactory stimulation
- Keywords
- Olfactory perception, Adrenal cortex hormones, Steroids, Education
- Medical subject headings
- Brain Injuries, Olfaction Disorders, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticosteroidsDrug
olfactory stimulationBehavioural
stimulation with odorants by sniffing 4 different odorants for a total of 5 minutes twice a day during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Olfactory disorder after brain trauma | Experimental | Recruited from 250 patients with moderate to severe traumatic brain injury in the Hodeskadeprosjektet (TBI) cohort. Treatment with (first) corticosteroids and (second) olfactory stimulation. Receives: Drug: corticosteroids; Behavioral: olfactory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who have improved olfaction perception (by at least 5 points on the Threshold-Discrimination-Identification (TDI) score
TDI score measured by Sniffin Sticks
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startJun 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Nils Kvermo, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565121
- Sponsor's protocol ID
- 2013/427
- Status last verified
- Jun 2020
- First submitted
- 28 Sep 2015
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bratt M, Skandsen T, Hummel T, Moen KG, Vik A, Nordgard S, Helvik AS. Frequency and prognostic factors of olfactory dysfunction after traumatic brain injury. Brain Inj. 2018;32(8):1021-1027. doi: 10.1080/02699052.2018.1469043. Epub 2018 May 9.
PubMed 29741969Bratt M, Moen KG, Nordgard S, Helvik AS, Skandsen T. Treatment of posttraumatic olfactory dysfunction with corticosteroids and olfactory training. Acta Otolaryngol. 2020 Sep;140(9):761-767. doi: 10.1080/00016489.2020.1767301. Epub 2020 Jun 3.
PubMed 32491937
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital: Prevalence and Treatment
- ClinicalTrials.gov ID
- NCT02565121
- Acronym / sponsor ID
- 2013/427
- Conditions
- Brain Injuries, Olfaction Disorders
- Keywords
- Olfactory perception, Adrenal cortex hormones, Steroids, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Jun 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Oct 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.
The aim of the study is to see whether patients with chronic smell impairment after brain injury benefit from a treatment that consists of corticosteroids, and then olfactory training in 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olfactory disorder after brain trauma | Experimental | Drug: corticosteroids, Behavioral: olfactory stimulationRecruited from 250 patients with moderate to severe traumatic brain injury in the Hodeskadeprosjektet (TBI) cohort. Treatment with (first) corticosteroids and (second) olfactory stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Registered in the TBI Database
- 18-65 years of age per 01.10. 2012
- Olfaction score by Sniffin Sticks Threshold-Discrimination-Identification (TDI) < 30 confirming dysosmia
Key exclusion criteria (8 listed)
- Unable to express senses.
- Unable to follow treatment and protocol
- pregnancy
- diabetes
- tendency to infections
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 |
|---|---|---|
| corticosteroids | Drug | Olfactory disorder after brain trauma |
| olfactory stimulationstimulation with odorants by sniffing 4 different odorants for a total of 5 minutes twice a day during 3 months | Behavioural | Olfactory disorder after brain trauma |
Primary outcome
number of patients who have improved olfaction perception (by at least 5 points on the Threshold-Discrimination-Identification (TDI) score
Time frame: 1 year
TDI score measured by Sniffin Sticks
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 9 Jun 2020.
- Background: PubMed 29741969Bratt M, Skandsen T, Hummel T, Moen KG, Vik A, Nordgard S, Helvik AS. Frequency and prognostic factors of olfactory dysfunction after traumatic brain injury. Brain Inj. 2018;32(8):1021-1027. doi: 10.1080/02699052.2018.1469043. Epub 2018 May 9.
- Results publication: PubMed 32491937Bratt M, Moen KG, Nordgard S, Helvik AS, Skandsen T. Treatment of posttraumatic olfactory dysfunction with corticosteroids and olfactory training. Acta Otolaryngol. 2020 Sep;140(9):761-767. doi: 10.1080/00016489.2020.1767301. Epub 2020 Jun 3.
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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.
Nils Kvermo study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corticosteroids and olfactory stimulation in people with Brain Injuries and Olfaction Disorders, run by St. Olavs Hospital at 1 site in Norway.
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 3 inclusion and 8 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 9 Jun 2020. 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 Norway. 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?
number of patients who have improved olfaction perception (by at least 5 points on the Threshold-Discrimination-Identification (TDI) score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565121, which also lists 2 linked publications.
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 9 Jun 2020.