Trial · NCT02977728
Olfactory Function in Patients With Acute Mild Traumatic Brain Injury
NCT02977728, Completed, Hôpital de Viege
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Olfactory Function in Patients With Acute Mild Traumatic Brain Injury. Trials, record NCT02977728. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02977728
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Olfactory Function in Patients With Acute Mild Traumatic Brain Injury
- NCT number
- NCT02977728
- Status
- Completed
- Enrollment
- 42 participants, actual
- Lead sponsor
- Hôpital de Viege
- Conditions
- Mild Traumatic Brain Injury
- Interventions
- Olfactory Evaluation
- First posted
- 2016-11-30
- Last updated
- 2018-08-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the objective and subjective olfactory function in patients following an acute mild traumatic brain injury | 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. |
| Secondary | 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 | The investigators will assess anxiety levels by using the Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depressionAlso, the Hamilton Anxiety Rating Scale, a 14-item scale designed to assess anxiety severity, will be administered by the examiner. It has been suggested to reflect subclinical expression of anxiety disorders. |
| Secondary | 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 | The Trail Making Test version A and B will be use in order to evaluate visual attention and task switching. This test consists of connecting dots carrying numbers and letters. We will further use the Stroop test to evaluate inhibition and interference in our participants. In addition we will use the Digit symbol substitution test, which measures speed of information processing. Finally, we will assess working memory, attention and mental control by using the letter number sequencing portion of the WAIS. All these tests have been shown to be sensitive to TBI. We will further evaluate cognitive impairment by means of the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status). Offering valuable enhancements, the RBANS Update provides a brief, individually administered battery to measure the general cognitive profil. |
| Secondary | 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 | The investigators will use the Rivermead post-concussion symptoms questionnaire. It allows for determining the presence and severity of 16 post-concussion symptoms including somatic, cognitive and emotional symptoms |
| Secondary | Evaluate the olfactory system one year post-tbi by the use of the UPSIT | One year after the mild traumatic brain Injury | The investigators will send by mail the UPSIT: The University of Pennsylvania Smell Identification Test (UPSIT) one year post-injury. The UPSIT is a "scratch and sniff" test based on microencapsulated odorants which are released from the surface of strips by means of a pencil. The patient is asked to choose 40 odorants on a multiple-choice list comprising four items each. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Letter-Number Sequencing Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02977728
GET https://conductscience.org/api/trials/v1/NCT02977728/registered