Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital
NCT ID: NCT02565121
Last Updated: 2020-06-09
Study Results
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2013-06-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Olfactory disorder after brain trauma
Recruited from 250 patients with moderate to severe traumatic brain injury in the Hodeskadeprosjektet (TBI) cohort. Treatment with (first) corticosteroids and (second) olfactory stimulation.
corticosteroids
olfactory stimulation
stimulation with odorants by sniffing 4 different odorants for a total of 5 minutes twice a day during 3 months
Interventions
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corticosteroids
olfactory stimulation
stimulation with odorants by sniffing 4 different odorants for a total of 5 minutes twice a day during 3 months
Eligibility Criteria
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Inclusion Criteria
* 18-65 years of age per 01.10. 2012
* Olfaction score by Sniffin Sticks Threshold-Discrimination-Identification (TDI) \< 30 confirming dysosmia
Exclusion Criteria
* Unable to follow treatment and protocol
* pregnancy
* diabetes
* tendency to infections
* hypertonia
* dyspepsia
* interfering medication (hormonal treatment, NSAIDS, antidiabetics, barbiturates, fenitoin, carbamazepin, rifampicin, cyclophosphamides)
18 Years
65 Years
ALL
No
Sponsors
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Norwegian University of Science and Technology
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Nils Kvermo
Role: STUDY_DIRECTOR
St. Olavs Hospital
Locations
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ENT department St Olavs Hospital
Trondheim, , Norway
Countries
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References
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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.
Bratt 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.
Other Identifiers
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2013/427
Identifier Type: -
Identifier Source: org_study_id
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