Olfactory Function in Patients With Acute Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 主要终点
- Evaluate the objective and subjective olfactory function in patients following an acute mild traumatic brain injury
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluate the objective and subjective olfactory function in patients following an acute mild traumatic brain injury
时间窗: The investigators will evaluate the olfactory system within 24h following the trauma
The investigatos will assess several different aspects of olfactory function with the Sniffin' Sticks test.Threshold: At each trial 3 pens are presented in a randomized order, two of which contain the solvent and one the odorant at a certain dilution. The subjects' task is to detect the odour-containing pen.Discrimination: Odour discrimination will be assessed by presenting triplets of pens in a randomized order. Two of them contain the same odorant, while the third contains a different odorant. Subjects have to determine which of the three odour- containing pens smells different. Identification: Odour identification will be assessed by means of common odours, presented in 16 different sticks. Using a forced choice approach, participants will select the best descriptor from a list of four for each odorant.Subjective olfactory impairment:The investigators will use an adapted version of the Questionnaire of Olfactory Disorders to determine the changes in olfactory function.
次要结局
- Evaluate the anxiety levels in patients following an acute mild traumatic brain injury(The investigators will evaluate the anxiety levels within 24h following the trauma)
- Evaluate the cognitive profil of the patients following an acute mild traumatic brain injury(The investigators will evaluate the cognitive profils within 24h following the trauma)
- Evaluate the post-concussion symptoms in patients following an acute mild traumatic brain injury(The investigators will evaluate the post-concussion symptoms within 24h following the trauma)
- Evaluate the olfactory system one year post-tbi by the use of the UPSIT(One year after the mild traumatic brain Injury)