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Evaluation of Two Methods of Olfactory Rehabilitation in Post-viral Loss of Smell: Classic and Intensive (Odorat-Covid)

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ClinicalTrials.gov Identifier: NCT04598763
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

One of the most common causes of loss of smell is upper respiratory tract infection. These disorders can be quantitative (hyposmia or anosmia) or qualitative (parosmia or phantosmia). Loss of smell has been found as a major and frequent clinical sign of Sars Cov2 infection (more than 50% of patients screened at the CHU Nancy). Spontaneous recovery remains possible. It usually occurs in the first month . But when symptoms persist, the therapeutic management of post-viral anosmias is poorly codified in the literature. Olfactory rehabilitation could allow faster recovery and better quality, but the published protocols are numerous and could only be tested on small inhomogeneous series of patients (mixture of post-viral and post-traumatic hypo-ansomy). The significant increase in the population of patients suffering from post-viral anosmia following the current pandemic situation makes it possible to consider a prospective study aiming to compare two olfactory rehabilitation protocols: "classic" and "intensive" in a population of patients. suffering only from post-viral hypoanosmia.

Hypothesis: Intensive or classic olfactory rehabilitation allows better results than spontaneous recovery


Condition or disease Intervention/treatment Phase
Olfaction Disorders Other: smell the odors of the olfactory rehabilitation kit according to the classic or intensive method Not Applicable

Detailed Description:

80 patients will be recruited from among the patients consulting the otorhinolaryngology department of the Nancy CHRU for the assessment of viral post-infectious olfactory disorders.

The inclusion visit will be carried out during a standard routine care consultation with the following:

  • an endoscopic endonasal examination
  • the olfactory assessment (evaluation of smell by self-assessment, Dynachron-olfaction questionnaire, olfactory test by Sniffin 'Stick)

At the end of this assessment and after having received the information on the study and signed the consent form, the patients confirmed to be hypo-anosmic will then be randomized into 2 groups:

  • "classic" olfactory rehabilitation group
  • "intensive" olfactory rehabilitation group The rehabilitation kits (8 jars or 4 jars depending on the randomization group) will be provided to the patient with therapeutic education in their use.

The patient will carry out olfactory rehabilitation (intensive or classic) at home twice a day (morning and evening) for 32 weeks (i.e. 448 sessions). The patient will smell each odor for 10 seconds with an interval of 10 seconds between odors. Each training will be recorded by the patient in his olfactory rehabilitation agenda.

The patient will go again for a follow-up consultation for the renewal of his olfactory assessment at 4 months (follow-up visit 1) and at 8 months (follow-up visit 2) post-inclusion as part of the routine care of disorders of the smell post virus infection. In addition to the olfactory assessment during these visits, the investigator will also verify that the rehabilitation schedule is being kept.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Two Methods of Olfactory Rehabilitation in Post-viral Loss of Smell: Classic and Intensive
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : July 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
classic group
the "classic" group receives classic olfactory rehabilitation using 4 scents most used in the literature (rose, eucalyptus, lemon, clove)
Other: smell the odors of the olfactory rehabilitation kit according to the classic or intensive method
regardless of the randomization group, the patient will smell each odor for 10 seconds with a 10 second interval between odors.

intensive
the "intensive" group receiving olfactory rehabilitation using 8 scents (rose, eucalyptus, lemon, cloves, strawberries, cut grass, lavender, spruce).
Other: smell the odors of the olfactory rehabilitation kit according to the classic or intensive method
regardless of the randomization group, the patient will smell each odor for 10 seconds with a 10 second interval between odors.




Primary Outcome Measures :
  1. improvement in smell [ Time Frame: eight month ]

    The change in smell is based on the comparison of the results of the olfactory assessment after / before olfactory rehabilitation obtained from a single method out of the three carried out:

    Sniffin 'Stick Test Results: Threshold Test Score and Actual Identification Test Score.

    TI score: sum of the individual scores of the threshold and identification measures (TI score varying from 0 to 32). It is used to classify patients in terms of normosmia, hyposmia and functional anosmia based on normative values of "Sniffin 'Sticks" (according to the age and sex of each subject) with the threshold at the tenth percentile of the database provided in the study published by Hummel and Kobal.

    Self-assessment by patients using a digital scale of smell, from 0 (no smell) to 10 (normal smell)

    Self-assessment using the Dynachron-olfaction questionnaire:each question is used to assess the patient's feelings about his discomfort in the nose using a scale from 0 (no discomfort) to 10 (unbearable




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major patient
  • Patient with a sudden loss of smell> 5 weeks linked to a viral infection (including SARS-CoV-2) of the upper respiratory tract treated in the ENT department of the CHRU Nancy
  • Patient accepting olfactory rehabilitation
  • Patient presenting with hyposmia or anosmia (confirmed by the threshold and identification tests of the Sniffin 'Stick kit)
  • Patient affiliated to a social security scheme or beneficiary of such a scheme
  • Patient who has received full research information and signed an informed consent.

Exclusion Criteria:

  • Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code:

Pregnant woman, parturient or nursing mother Person deprived of liberty by a judicial or administrative decision, Person undergoing psychiatric treatment under Articles L.3212-1 and L.3213-1 of the Public Health Code Minor (non-emancipated) Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) Adult person unable to express consent and who is not the subject of a legal protection measure

  • Qualitative smell disorder (cacosmia, hyperosmia, phantosmia, parosmia)
  • Neurological, post-traumatic, neurodegenerative, congenital odor disorders
  • Post-infectious loss of smell> 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598763


Contacts
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Contact: Julie Lecomte +33 3 83 15 52 78 ju.lecomte@chru-nancy.fr
Contact: Duc Trung NGUYEN 03 83 15 54 09 dt.nguyen@chru-nancy.fr

Locations
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France
CHRU de Nancy Recruiting
Nancy, France, 54000
Contact: Duc Trung NGUYEN, MD, PhD, MPH    33383155409    dt.nguyen@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Duc Trung NGUYEN CHRU de Nancy
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04598763    
Other Study ID Numbers: 2020PI098
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases