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

NCT04598763 | Unknown

• 1 other identifier: 2020PI098
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Olfaction Disorders

Outcome Measures

Primary Outcomes (1)

• 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

  eight month

Study Arms (2)

classic group

OTHER

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

intensive

OTHER

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

Interventions

smell the odors of the olfactory rehabilitation kit according to the classic or intensive method OTHER

regardless of the randomization group, the patient will smell each odor for 10 seconds with a 10 second interval between odors.

classic group; intensive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Olfaction Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Duc Trung NGUYEN

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Lecomte

CONTACT

+33 3 83 15 52 78; ju.lecomte@chru-nancy.fr

Duc Trung NGUYEN

CONTACT

03 83 15 54 09; dt.nguyen@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: January 1, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-07

Locations

FR (1)