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

Not Applicable

Completed

• Conditions: Olfaction Disorders; Brain Injuries
• Interventions: Drug: corticosteroids; Behavioral: olfactory stimulation

• Registration Number: NCT02565121
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olfactory disorder after brain trauma	olfactory stimulation	Recruited from 250 patients with moderate to severe traumatic brain injury in the Hodeskadeprosjektet (TBI) cohort. Treatment with (first) corticosteroids and (second) olfactory stimulation.
Olfactory disorder after brain trauma	corticosteroids	Recruited from 250 patients with moderate to severe traumatic brain injury in the Hodeskadeprosjektet (TBI) cohort. Treatment with (first) corticosteroids and (second) olfactory stimulation.

Primary Outcome Measures

Name	Time	Method
number of patients who have improved olfaction perception (by at least 5 points on the Threshold-Discrimination-Identification (TDI) score	1 year	TDI score measured by Sniffin Sticks

Trial Locations

Locations (1)

ENT department St Olavs Hospital; 🇳🇴 Trondheim, Norway