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Clinical Trials/NCT02565121
NCT02565121
Completed
Not Applicable

Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital: Prevalence and Treatment

St. Olavs Hospital1 site in 1 country20 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
corticosteroids
Conditions
Brain Injuries
Sponsor
St. Olavs Hospital
Enrollment
20
Locations
1
Primary Endpoint
number of patients who have improved olfaction perception (by at least 5 points on the Threshold-Discrimination-Identification (TDI) score
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
August 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Registered in the TBI Database
  • 18-65 years of age per 01.
  • 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
  • tendency to infections
  • hypertonia
  • dyspepsia
  • interfering medication (hormonal treatment, NSAIDS, antidiabetics, barbiturates, fenitoin, carbamazepin, rifampicin, cyclophosphamides)

Arms & Interventions

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.

Intervention: corticosteroids

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.

Intervention: olfactory stimulation

Outcomes

Primary Outcomes

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

Study Sites (1)

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