Clinical trial NCT04799977: COVID-19: Post-covid Olfactory Disorders Assessment
Official title: Persistent Olfactory Loss After COVID-19 : Olfactive Disorder, Psychiatric and/or Cognitive Assessments With and Without a Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Olfaction Disorders
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients who presented with anosmia during their COVID19 infection (proven by a PCR+ test) and presenting at the ENT department consultation in university hospital more than 6 weeks after the end of symptoms,

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sniffin Stick Tests (score TDI)
timeFrame: 12 months : Evalation at the beginning and the end.
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: 12 months : Evaluation at the beginning and the end.
measure: Situational anxiety and anxiety trait inventory (STAI-Y)
timeFrame: 12 months : Evaluation at the beginning and the end.
measure: PTSD checklist for DSM-5 (PCL-5)
timeFrame: 12 months : Evaluation at the beginning and the end.
measure: GREMOTS
timeFrame: 12 months : Evaluation at the beginning and the end.
measure: PPT
timeFrame: 12 months : Evaluation at the beginning and the end.
measure: GROBER BUSCHKE
timeFrame: 12 months : Evaluation at the beginning and the end.
measure: TAP (Test of Attentional Performance)
timeFrame: 12 months : Evaluation at the beginning and the end.
measure: TODA2 Olfactive Identification
timeFrame: 12 months : Evaluation at the beginning and the end.
measure: Snaith-HAmilton Pleasure Scale (SHAPS)
timeFrame: 12 months : Evaluation at the beginning and the end.
measure: Inventory/Apathy Scale
timeFrame: 12 months : Evaluation at the beginning and the end.
measure: Olfactory Quality of life assessment - Short Version of questionnaire of olfactory disorders
timeFrame: 12 months : Evaluation at the beginning and the end.
measure: General quality of life assessment (SF-36)
timeFrame: 12 months : Evaluation at the beginning and the end.
measure: The French quality of life and diet scale (QV-AF)
timeFrame: 12 months : Evaluation at the beginning and the end.
Other outcomes:
Locations:
city: Nice
country: France
facility: IUFC
Study officials:
References: