Olfaction DisordersOdorat-CovidNCT04598763
Evaluation of Two Methods of Olfactory Rehabilitation in Post-viral Loss of Smell: Classic and Intensive
A study testing smell the odors of the olfactory rehabilitation kit according to the classic or intensive method in people with Olfaction Disorders, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olfaction Disorders
- What is being tested?
- smell the odors of the olfactory rehabilitation kit according to the classic or intensive method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Nancy, 54000
Duc Trung NGUYEN, MD, PhD, MPH, 33383155409, dt.nguyen@chru-nancy.fr
About this study
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
Read the 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.
- Conditions
- Olfaction Disorders
- Being tested
- smell the odors of the olfactory rehabilitation kit according to the classic or intensive method
- Medical subject headings
- Olfaction Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smell the odors of the olfactory rehabilitation kit according to the classic or intensive methodOther
regardless of the randomization group, the patient will smell each odor for 10 seconds with a 10 second interval between odors.
| Study group | Role | What they receive |
|---|---|---|
| classic group | Other | the "classic" group receives classic olfactory rehabilitation using 4 scents most used in the literature (rose, eucalyptus, lemon, clove) Receives: 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). Receives: Other: smell the odors of the olfactory rehabilitation kit according to the classic or intensive method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: eight month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2020
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfaction DisordersStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duc Trung NGUYEN, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598763
- Sponsor's protocol ID
- 2020PI098
- Acronym
- Odorat-Covid
- Status last verified
- Jul 2020
- First submitted
- 15 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Methods of Olfactory Rehabilitation in Post-viral Loss of Smell: Classic and Intensive
- ClinicalTrials.gov ID
- NCT04598763
- Acronym / sponsor ID
- Odorat-Covid / 2020PI098
- Conditions
- Olfaction Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classic group | Other | Other: smell the odors of the olfactory rehabilitation kit according to the classic or intensive methodthe "classic" group receives classic olfactory rehabilitation using 4 scents most used in the literature (rose, eucalyptus, lemon, clove) |
| intensive | Other | Other: smell the odors of the olfactory rehabilitation kit according to the classic or intensive methodthe "intensive" group receiving olfactory rehabilitation using 8 scents (rose, eucalyptus, lemon, cloves, strawberries, cut grass, lavender, spruce). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smell the odors of the olfactory rehabilitation kit according to the classic or intensive methodregardless of the randomization group, the patient will smell each odor for 10 seconds with a 10 second interval between odors. | Other | classic group, intensive |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duc Trung NGUYEN principal investigator
CHRU de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smell the odors of the olfactory rehabilitation kit according to the classic or intensive method in people with Olfaction Disorders, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Lecomte (+33 3 83 15 52 78, ju.lecomte@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in smell (time frame: eight month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.