Clinical trial NCT02977728: Olfactory Function in Patients With Acute Mild Traumatic Brain Injury
Official title: Olfactory Function in Patients With Acute Mild Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Traumatic Brain Injury
Keywords: MTBI
olfaction
acute
Lead sponsor: Hôpital de Viege
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will include a total of 30 patients with acute (into the first 24 hours) mild TBI and the same number of patients with an orthopaedic injury not involving the head.

Brief summary: In this project the investigators aim to evaluate olfactory and non-olfactory function in patients within the first 24h following a mild traumatic brain injury (acute mTBI) and compare their results to a group of age and sex matched control patients suffering from an orthopedic injury 24h prior to testing. The investigators then aim to follow them up 1 year after the trauma

Detailed description: This is a research project in which health-related personal data is collected; the investigators will use coded data. Further this project is a cross-sectional study.

Procedure Potential participants will be identified via the collaborating physicians who will inquire about the interest of the patient to participate. The investigators will then approach patients in their room and inform them about the study. If the patient is interested they will sign the consent form and be included in the study.

Session 1: Session 1 will be carried out directly after inclusion into the study. First the investigators will execute olfactory tests subjective olfactory impairment, Sniffin' Sticks test (threshold, discrimination, identification) and subjective odor evaluation. This will approximately last one hour (with breaks). Participants will then have a break of 15-60 minutes. In the following the investigators will carry out the non-olfactory tests; this will last another 45 minutes.

Session 2: During inclusion, participants will be asked to give their contact details (email and postal address). 10 months after the first session, the investigators will contact them by email. The investigators will then send them a booklet of the UPSIT by mail. Participants will be asked to fill out the test and send it back with a prepaid envelope.

Recruitment Potential participants will be identified via the collaborating physicians who will inquire about the interest of the patient to participate. The investigators will then approach patients in their room and inform them about the study. If the patient is interested they will sign the consent form and be included in the study. Specifically, the responsible researcher will perform consecutive ongoing recruitment through daily clinical practice. The investigators will also carry out the screening.

Criteria for withdrawal / discontinuation of participants:

The participant participation in this study is strictly voluntary. They may refuse to participate or may discontinue their participation at any time without explanation, and without penalty or loss of benefits to which they are otherwise entitled. If they decide not to participate, or if they discontinue their participation, they will suffer no prejudice regarding medical care or their participation in any other research studies. They will be informed of any new findings that may affect their willingness to continue their participation.

The study doctor may end the participant participation for administrative reasons unrelated to the purpose of the study. In addition, the Swiss Ethics Committees on research involving humans may terminate the study.

Eligibility criteria: Inclusion Criteria:

* The investigators will include patients aged between 18 and 55 years old
* admitted to the Hospital Visp in the 24 hours preceding the testing
* MTBI group: The investigators will include patients who have been diagnosed with a mild traumatic brain injury (Glasgow Coma Scale 13 and above) within 24h before inclusion.
* Orthopaedic Group: The investigators will include patients who have been diagnosed with a traumatic orthopaedic injury to one of their limbs within 24 hours before inclusion.

Exclusion Criteria:

* are under the influence of alcohol or drugs during the time of testing
* patients with a known history of traumatic brain injury (e.g., a prior concussion)
* patients with a known and pharmacologically treated neurological or psychiatric diseases
* patients who have suffered from an injury to the face (such as a broken nose)
* patients who do not have German, French or English as their first language
* For the orthopaedic group : The investigators will exclude patients who, in addition to their orthopaedic trauma, have suffered from a brain injury due to their trauma.

Primary outcomes:
measure: Evaluate the objective and subjective olfactory function in patients following an acute mild traumatic brain injury
timeFrame: The investigators will evaluate the olfactory system within 24h following the trauma
Secondary outcomes:
measure: Evaluate the anxiety levels in patients following an acute mild traumatic brain injury
timeFrame: The investigators will evaluate the anxiety levels within 24h following the trauma
measure: Evaluate the cognitive profil of the patients following an acute mild traumatic brain injury
timeFrame: The investigators will evaluate the cognitive profils within 24h following the trauma
measure: Evaluate the post-concussion symptoms in patients following an acute mild traumatic brain injury
timeFrame: The investigators will evaluate the post-concussion symptoms within 24h following the trauma
measure: Evaluate the olfactory system one year post-tbi by the use of the UPSIT
timeFrame: One year after the mild traumatic brain Injury
Other outcomes:
Locations:
Study officials:
affiliation: Sacre-Coeur Hospital
name: Johannes Frasnelli, Ph.D.
role: STUDY_DIRECTOR
References: