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

Primary Purpose

Olfaction Disorders

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
smell the odors of the olfactory rehabilitation kit according to the classic or intensive method
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Olfaction Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

classic group

intensive

Arm Description

the "classic" group receives classic olfactory rehabilitation using 4 scents most used in the literature (rose, eucalyptus, lemon, clove)

the "intensive" group receiving olfactory rehabilitation using 8 scents (rose, eucalyptus, lemon, cloves, strawberries, cut grass, lavender, spruce).

Outcomes

Primary Outcome Measures

improvement in smell
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

Secondary Outcome Measures

Full Information

First Posted
October 15, 2020
Last Updated
October 21, 2020
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT04598763
Brief Title
Evaluation of Two Methods of Olfactory Rehabilitation in Post-viral Loss of Smell: Classic and Intensive
Acronym
Odorat-Covid
Official Title
Evaluation of Two Methods of Olfactory Rehabilitation in Post-viral Loss of Smell: Classic and Intensive
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olfaction Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
classic group
Arm Type
Other
Arm Description
the "classic" group receives classic olfactory rehabilitation using 4 scents most used in the literature (rose, eucalyptus, lemon, clove)
Arm Title
intensive
Arm Type
Other
Arm Description
the "intensive" group receiving olfactory rehabilitation using 8 scents (rose, eucalyptus, lemon, cloves, strawberries, cut grass, lavender, spruce).
Intervention Type
Other
Intervention Name(s)
smell the odors of the olfactory rehabilitation kit according to the classic or intensive method
Intervention Description
regardless of the randomization group, the patient will smell each odor for 10 seconds with a 10 second interval between odors.
Primary Outcome Measure Information:
Title
improvement in smell
Description
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
Time Frame
eight month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Lecomte
Phone
+33 3 83 15 52 78
Email
ju.lecomte@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Duc Trung NGUYEN
Phone
03 83 15 54 09
Email
dt.nguyen@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duc Trung NGUYEN
Organizational Affiliation
CHRU de Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duc Trung NGUYEN, MD, PhD, MPH
Phone
33383155409
Email
dt.nguyen@chru-nancy.fr

12. IPD Sharing Statement

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

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