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

NCT02565121 | Completed

• 1 other identifier: 2013/427
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries; Olfaction Disorders

Keywords

Olfactory perception; Adrenal cortex hormones; Steroids; Education

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Study Arms (1)

Olfactory disorder after brain trauma

EXPERIMENTAL

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

Interventions

corticosteroids DRUG

Olfactory disorder after brain trauma

olfactory stimulation BEHAVIORAL

stimulation with odorants by sniffing 4 different odorants for a total of 5 minutes twice a day during 3 months

Olfactory disorder after brain trauma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Registered in the TBI Database
• years of age per 01.10. 2012
• Olfaction score by Sniffin Sticks Threshold-Discrimination-Identification (TDI) \< 30 confirming dysosmia

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

ENT department St Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

• 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.

  PMID: 29741969 BACKGROUND

• 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.

  PMID: 32491937 RESULT

MeSH Terms

Conditions

Brain Injuries; Olfaction Disorders; Anosmia

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Nils Kvermo

  St. Olavs Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 1, 2015
• Study Start: June 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

NO (1)