Olfactory Function in Patients With Acute Mild Traumatic Brain Injury
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Observational [Patient Registry]

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.
    

Intervention name(s): Olfactory Evaluation
Intervention type(s): Other
Intervention description(s): The investigators will evaluate the olfactory system of all participants by the use of the Sniffin'Sticks batterie
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.
      
Keywords: MTBI; olfaction; acute