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NCT02565121 Clinical Trial

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

Brain Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02565121
Other study ID # 2013/427
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2013
Est. completion date August 2015

Study information
Verified date June 2020
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Norway ENT department St Olavs Hospital Trondheim

Sponsors (2)
Lead Sponsor Collaborator
St. Olavs Hospital Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Bratt M, Moen KG, Nordgård S, Helvik AS, Skandsen T. Treatment of posttraumatic olfactory dysfunction with corticosteroids and olfactory training. Acta Otolaryngol. 2020 Jun 3:1-7. doi: 10.1080/00016489.2020.1767301. [Epub ahead of print] — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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