Back to resultsOlfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital
Primary Purpose
Brain Injuries, Olfaction Disorders
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
corticosteroids
olfactory stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injuries focused on measuring Olfactory perception, Adrenal cortex hormones, Steroids, Education
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- ENT department St Olavs Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Olfactory disorder after brain trauma
Arm Description
Recruited from 250 patients with moderate to severe traumatic brain injury in the Hodeskadeprosjektet (TBI) cohort. Treatment with (first) corticosteroids and (second) olfactory stimulation.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02565121
First Posted
September 28, 2015
Last Updated
June 4, 2020
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02565121
Brief Title
Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital
Official Title
Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital: Prevalence and Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Olfaction Disorders
Keywords
Olfactory perception, Adrenal cortex hormones, Steroids, Education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olfactory disorder after brain trauma
Arm Type
Experimental
Arm Description
Recruited from 250 patients with moderate to severe traumatic brain injury in the Hodeskadeprosjektet (TBI) cohort. Treatment with (first) corticosteroids and (second) olfactory stimulation.
Intervention Type
Drug
Intervention Name(s)
corticosteroids
Intervention Type
Behavioral
Intervention Name(s)
olfactory stimulation
Intervention Description
stimulation with odorants by sniffing 4 different odorants for a total of 5 minutes twice a day during 3 months
Primary Outcome Measure Information:
Title
number of patients who have improved olfaction perception (by at least 5 points on the Threshold-Discrimination-Identification (TDI) score
Description
TDI score measured by Sniffin Sticks
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Kvermo
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
ENT department St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
29741969
Citation
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.
Results Reference
background
PubMed Identifier
32491937
Citation
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.
Results Reference
result
Learn more about this trial
Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital
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