COVID-19: Post-covid Olfactory Disorders Assessment

Olfaction Disorders Clinical Trial

Official title:

Persistent Olfactory Loss After COVID-19 : Olfactive Disorder, Psychiatric and/or Cognitive Assessments With and Without a Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799977
• Other study ID #: 21IUFCcovid01
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Clair VANDERSTEEN
• Phone: 334 92 03 17 05
• Email: vandersteen.c[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Covid 19 cause an olfactory loss in more than 80% of cases. This loss most often regresses but leaves 20% of patients with an olfactory complaint, particularly with regard to the quality of daily life. The neuro-cognitive implications involved with COVID19 and the consequences of persistent olfactory loss remain unknown. The effectiveness of therapeutic management, in particular olfactory re-education, has not yet been clarified. Objectives are the assessment of patients olfactory disorders, psychiatrics and neurocognitives specificities after a COVID, before and after treatment or specific cares.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2022
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults patient,
• anosmia during a COVID19 acute infection (PCR+) and persistant olfactive disoders at least 6 weeks after symptoms disappeared.

Exclusion Criteria:

• preexisting smell loss.

Related Conditions & MeSH terms

• Olfaction Disorders

Locations

Country	Name	City	State
France	IUFC	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sniffin Stick Tests (score TDI)	The subjective olfactory losses and recoveries are most often evaluated using the "Sniffin 'Sticks Test®", the current gold standard of objective olfactory tests allowing in a single examination to group together: the definition of an olfactory threshold, olfactory discrimination and olfactory identification in the form of an overall TDI score. Olfactory function using psychophysical tests before and after treatment or specific cares : Sniffin Stick Tests (score TDI). Results can classified patients in Anosmic (TDI<16,25), Hyposmic (16,25	12 months : Evalation at the beginning and the end.
Secondary	Hamilton Depression Rating Scale (HDRS)	The HDRS is used to assess the severity and progression of a patient's depressive state during a structured interview. This is a hetero-questionnaire consisting of 21 items completed in a few minutes by the examiner after an interview of at least 30 minutes. Before and after treatment or specific cares. Min-Max = 10-21. 10 < score < 13 = lights depression symptoms; 14	12 months : Evaluation at the beginning and the end.
Secondary	Situational anxiety and anxiety trait inventory (STAI-Y)	The STAI is a self-administered questionnaire comprising 40 items. This scale consists of 2 parts: one evaluating the anxiety-state (AE) which reflects the current emotional state and the other evaluating trait anxiety (AT) which reflects the usual emotional state. Before and after treatment or specific cares. Each score can vary from 20 to 80 with a "very high" (> 65), "high" (56-65), "average" (46-55), "low" (36-45) and "very low" (	12 months : Evaluation at the beginning and the end.
Secondary	PTSD checklist for DSM-5 (PCL-5)	The PCL-5 is a 20-item self-report that measures the 20 PTSD symptoms of DSM-5. The goals of PCL-5 are many, such as monitoring changes in symptoms during and after treatment, identifying individuals with PTSD, and making a provisional diagnosis of PTSD. Before and after treatment or specific cares. This self-rated scale scores each symptom from 0 to 4. Min-Max (better)=0-20. Interrelationships assessment between psychophysical tests and theses results.	12 months : Evaluation at the beginning and the end.
Secondary	GREMOTS	GREMOTS is a speech assessment test for neurological pathologies. This battery of tests takes into account the latest scientific development in the field and evaluates the different psycholinguistic variables of language. It also aims to detect disorders from the early stage of the disease. It componed of differents subtypes. We used the denomination and verification tasks. Semantic verification task: Min-Max=0-18. The cut-off score is between 5 and 25 percentil (inferior to 10-14). Denomination task: Min-Max=0-36. The cut-off score is between 5 and 25 percentil (inferior to 31-34).	12 months : Evaluation at the beginning and the end.
Secondary	PPT	The Pyramids and Palm Trees Test is a commonly used test of associative semanticknowledge comprising 52 items. In this test, participants are shown a stimulus (e.g., a pyramid) and asked to match it toeither of two images: A target (e.g., a palm tree) or a distracter (e.g., a fir tree). Subjects are required to use explicit semantic information of encyclopedic (e.g., pyramid: Palm tree vs. fir tree) or functional (e.g., wood: Saw vs. hammer) nature to select the correct match. Min-Max: 0-52. The 5% cut-off score corresponds to a Z-score of -1.65.	12 months : Evaluation at the beginning and the end.
Secondary	GROBER BUSCHKE	Grober and Buschke's is a commonly used test assesses verbal memory and is made up of 16 items belonging to 16 different semantic categories. The indexed reminder makes it possible to check the efficiency of the encoding and to dissociate memory disorders according to their type. Min-Max: 0-48. The cut-off score is inferior to 25 percentil.	12 months : Evaluation at the beginning and the end.
Secondary	TAP (Test of Attentional Performance)	The investigators used two tasks: the alertness task and the sustained attention task. In the alertness's task, reaction time is examined under two conditions. In the sustained attention task, a sequence of stimuli is presented on the monitor. The stimuli vary in a range of feature dimensions: colour, shape, size and filling. In order to adapt the difficulty of the task to the performance level of a subject, different levels of difficulty, that is, reactions to "shape" only or to "colour or shape", may be selected. Norms are betwaeen 19 and 89 for the alertness task and between 19 and 72 in sustained attention task.	12 months : Evaluation at the beginning and the end.
Secondary	TODA2 Olfactive Identification	The olfactory test was developed by the CoBTeK laboratory. It's an electronic test with mobile application which is componed of two tasks: a treshold task and an identification task. This task assess more precisely odor identification disorders by presenting semantic distractors at the higer treshold level. Min-Max treshold score: 1-4. Min-Max identification score: 0-24	12 months : Evaluation at the beginning and the end.
Secondary	Snaith-HAmilton Pleasure Scale (SHAPS)	The SHAPS is a 14-item self-administered questionnaire designed to assess a patient's hedonic capacity under different circumstances of daily life. Before and after treatment or specific cares. Min-Max = 0-14. Score >3 Anhédonic symptom; Interrelationships assessment between psychophysical tests and theses results	12 months : Evaluation at the beginning and the end.
Secondary	Inventory/Apathy Scale	The principle of the Apathy Inventory (IA) is to obtain information on the presence of apathy in patients with neurological disorders. The investigators used the clinical version of the Apathy Inventory. It assess the 4 clinical dimensions: - Emotional blunting - Lack of initiative - Lack of interest- Social interactions. Score for each dimension: 0= no problem; 2= moderate problem; 4= major problem. Min-Max total score= 0-16..	12 months : Evaluation at the beginning and the end.
Secondary	Olfactory Quality of life assessment - Short Version of questionnaire of olfactory disorders	Specific quality of life related to olfaction disorders concerning Social, eating, anxiety and daily annoyance related behaviors. Min-Max = 0-21, the higher is the score, the better is olfactory quality of life	12 months : Evaluation at the beginning and the end.
Secondary	General quality of life assessment (SF-36)	General quality of life score. Two scores related to an aggregated physical score and a mental score. Normatives values are near 50 for both. Less than 45 is worst subdomain quality of life, better than 55 is better subdomain quality of life. MCID = 5	12 months : Evaluation at the beginning and the end.
Secondary	The French quality of life and diet scale (QV-AF)	The QV-AF is a scale developed and validated in French to assess the quality of life in adults and in particular the relationship to diet. 4 subscales: diet / pleasure dimension, diet / relationship dimension, diet / psychology dimension, diet and physical condition dimension. Before and after treatment or specific cares. Min-Max (better)=0-400. Interrelationships assessment between psychophysical tests and theses results.	12 months : Evaluation at the beginning and the end.