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Completed

NCT Number: NCT02565121

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ENT department St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Corticosteroids

Drug

Olfactory stimulation

Behavioral

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 1, 2015
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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