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

• Sponsor: St. Olavs Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02565121
• Collaborator: Norwegian University of Science and Technology (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 26
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Injuries; Olfaction Disorders	Drug: corticosteroids; Behavioral: olfactory stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Olfaction Disorders in Patients Included in The Trauma Brain Injury (TBI) Database at Trondheim University Hospital: Prevalence and Treatment
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: corticosteroids; Behavioral: olfactory stimulation; stimulation with odorants by sniffing 4 different odorants for a total of 5 minutes twice a day during 3 months

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ENT department St Olavs Hospital	Trondheim		Norway

Sponsors and Collaborators

• St. Olavs Hospital
• Norwegian University of Science and Technology

Investigators

• Study Director: Nils Kvermo, St. Olavs Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bratt M, Skandsen T, Hummel T, Moen KG, Vik A, Nordgård 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.

• Responsible Party: St. Olavs Hospital
• ClinicalTrials.gov Identifier: NCT02565121
• Other Study ID Numbers: 2013/427
• First Posted: Oct 1, 2015
• Last Update Posted: Jun 9, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by St. Olavs Hospital: Olfactory perception; Adrenal cortex hormones; Steroids; Education
• Additional relevant MeSH terms: Brain Injuries; Olfaction Disorders; Wounds and Injuries

Study Results

No Results Posted as of Jun 9, 2020