Adult With Stroke and Olfaction's ComplaintRE-OLFNCT04703218
REEDUCATION OF OLFACTORY DISORDERS AFTER A CEREBRAL VASCULAR ACCIDENT IN ADULTS
A study testing olfactory rehabilitation in people with Adult With Stroke and Olfaction's Complaint, run by University Hospital, Caen at 1 site in France.
Trial summary
Study context: The literature identifies more and more research revealing olfactory disorders, with a high frequency after an acquired brain injury. So far, studies have mainly focused on post-traumatic and post-infectious olfactory disorders of the upper airways. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adult With Stroke and Olfaction's Complaint
- What is being tested?
- olfactory rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2022to 16 Nov 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient under 65 in order to avoid presbyosmia bias,
- Patient suffering from an ischemic and / or hemorrhagic stroke dating at least 3 months,
- Patient followed in the SRH department and / or in post-stroke consultation,
- French-speaking patient,
- Patient affiliated to the social security scheme,
- Patient having signed the informed consent.
Who cannot join
- Patient with a TDI score greater than 30.5 on the SST,
- Patient with global aphasia: score <25 on the oral comprehension subtest of MT86 sentences (1),
- Person under legal protection (guardianship, curatorship, safeguard of justice),
- Patient treated with corticosteroids, corticosteroids, steroids, antihistamines and antibiotics which may have repercussions on olfaction,
- History of trauma to the face,
- History of ENT surgery,
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- Chronic rhinitis,
- Infection of the ENT sphere in the 15 days preceding inclusion,
- Neurodegenerative pathology,
- Parosmia, phantosmia or cacosmia,
- History of systemic chemotherapy or radiotherapy to the head.
Trial locations and contacts
1 site in 1 country.
About this study
Study context:
The literature identifies more and more research revealing olfactory disorders, with a high frequency after an acquired brain injury. So far, studies have mainly focused on post-traumatic and post-infectious olfactory disorders of the upper airways. There is scarcer data available on the olfactory disorders occurring after stroke. A recent study found 43.6% of patients with a loss of olfactory function after a stroke (2). This type of disorder can have repercussions in everyday life and endanger people, not being able to smell a burning odor or gas fumes. In addition, patients frequently describe loss of pleasure associated with these olfactory disorders (3). Tests allowing the evaluation of these difficulties exist but remain little used in clinical routine (4). These psychophysical tests allow a quantitative analysis of the olfactory capacities of subjects through various measures such as the detection threshold (T SST sub-score), discrimination (D SST sub-score) or the identification of an odor. (SST sub-score I). Some studies have shown a reduction in olfactory disturbances following specific training. Thus, Hummel et al. proposed a self-stimulation protocol to patients whose olfactory dysfunction was due to various aetiologies (post-infectious, post-traumatic or idiopathic) (5). People were to smell 4 scents twice a day for 12 weeks. The results show an improvement in the olfaction of the patients, while no change was noted in the subjects who did not perform the training. Lehrer et al. obtained similar results in patients with head trauma (CT) after 3 months of training (6). However, no study has looked at the effect of specific olfaction training in post-stroke patients. The few data available in the literature suggest that these disorders are common after stroke.
Read more
Objectives :
We propose an open, randomized controlled study, comparing the SST score between the group of patients who received olfactory training and the group who received standard rehabilitation.
Material and methods :
In the treatment of post-stroke olfactory disorders, we will suggest to patients hospitalized in SSR or followed in consultation to participate in a controlled, randomized open study.
All included patients will be assessed using the SST and the modified ASOF quality of life questionnaire (7). After randomization, patients in the treatment group will benefit from a presentation of specific olfaction training. This training consists of smelling 4 scents twice a day using scent sticks, for 12 weeks. At the end of these 12 weeks, a post-protocol evaluation including the SST, the modified ASOF quality of life questionnaire and a measurement of any side effects related to training will be offered.
Hypothesis tested:
The aim of this work is to evaluate the effectiveness of a specific olfaction training protocol in patients with olfaction disorders following stroke.
- Being tested
- olfactory rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory rehabilitationOther
Olfactory rehabilitation consists of smelling 4 scents twice a day using scent sticks, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patients with stroke and olfaction disorder benefiting from specific olfaction training. | Experimental | Not described Receives: Other: olfactory rehabilitation |
| Patients with stroke and olfactory disorder benefiting from standard post-stroke rehabilitation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
TDI score obtained in SST after the training period (12 weeks)
Measured: 3 months
Secondary outcomes (7)
Score obtained on the ASOF quality of life questionnaire modified after training (12 weeks)
Measured: 3 months
T, D and I sub-scores obtained in SST after training (12 weeks)
Measured: 3 months
Number of complaints about side effects and possible discomfort related to training
Measured: 3 months and 6 months
Number of training stops (training < 12 weeks)
Measured: 3 months
score obtained in the SST after training (12 weeks)
Measured: 3 months
TDI score obtained at SST 3 months after the end of training (at 24 weeks)
Measured: 6 months
Percentage of patients changing category according to the thresholds validated by the SST (anosmia, hyposmia, normosmia).
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start11 Jan 2022
- Primary completion16 Nov 2022
- Study completion16 Nov 2022
Why it stopped: lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult With Stroke and Olfaction's ComplaintStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703218
- Sponsor's protocol ID
- 20-055
- Acronym
- RE-OLF
- Status last verified
- Jul 2025
- First submitted
- 7 Jan 2021
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REEDUCATION OF OLFACTORY DISORDERS AFTER A CEREBRAL VASCULAR ACCIDENT IN ADULTS
- ClinicalTrials.gov ID
- NCT04703218
- Acronym / sponsor ID
- RE-OLF / 20-055
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of patients
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 11 Jan 2021 (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.
Study context:
The literature identifies more and more research revealing olfactory disorders, with a high frequency after an acquired brain injury. So far, studies have mainly focused on post-traumatic and post-infectious olfactory disorders of the upper airways. There is scarcer data available on the olfactory disorders occurring after stroke. A recent study found 43.6% of patients with a loss of olfactory function after a stroke (2). This type of disorder can have repercussions in everyday life and endanger people, not being able to smell a burning odor or gas fumes. In addition, patients frequently describe loss of pleasure associated with these olfactory disorders (3). Tests allowing the evaluation of these difficulties exist but remain little used in clinical routine (4). These psychophysical tests allow a quantitative analysis of the olfactory capacities of subjects through various measures such as the detection threshold (T SST sub-score), discrimination (D SST sub-score) or the identification of an odor. (SST sub-score I). Some studies have shown a reduction in olfactory disturbances following specific training. Thus, Hummel et al. proposed a self-stimulation protocol to patients whose olfactory dysfunction was due to various aetiologies (post-infectious, post-traumatic or idiopathic) (5). People were to smell 4 scents twice a day for 12 weeks. The results show an improvement in the olfaction of the patients, while no change was noted in the subjects who did not perform the training. Lehrer et al. obtained similar results in patients with head trauma (CT) after 3 months of training (6). However, no study has looked at the effect of specific olfaction training in post-stroke patients. The few data available in the literature suggest that these disorders are common after stroke.
Objectives :
We propose an open, randomized controlled study, comparing the SST score between the group of patients who received olfactory training and the group who received standard rehabilitation.
Material and methods :
In the treatment of post-stroke olfactory disorders, we will suggest to patients hospitalized in SSR or followed in consultation to participate in a controlled, randomized open study.
All included patients will be assessed using the SST and the modified ASOF quality of life questionnaire (7). After randomization, patients in the treatment group will benefit from a presentation of specific olfaction training. This training consists of smelling 4 scents twice a day using scent sticks, for 12 weeks. At the end of these 12 weeks, a post-protocol evaluation including the SST, the modified ASOF quality of life questionnaire and a measurement of any side effects related to training will be offered.
Hypothesis tested:
The aim of this work is to evaluate the effectiveness of a specific olfaction training protocol in patients with olfaction disorders following stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with stroke and olfaction disorder benefiting from specific olfaction training. | Experimental | Other: olfactory rehabilitation |
| Patients with stroke and olfactory disorder benefiting from standard post-stroke rehabilitation | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient under 65 in order to avoid presbyosmia bias,
- Patient suffering from an ischemic and / or hemorrhagic stroke dating at least 3 months,
- Patient followed in the SRH department and / or in post-stroke consultation,
- French-speaking patient,
- Patient affiliated to the social security scheme,
Key exclusion criteria (11 listed)
- Patient with a TDI score greater than 30.5 on the SST,
- Patient with global aphasia: score <25 on the oral comprehension subtest of MT86 sentences (1),
- Person under legal protection (guardianship, curatorship, safeguard of justice),
- Patient treated with corticosteroids, corticosteroids, steroids, antihistamines and antibiotics which may have repercussions on olfaction,
- History of trauma to the face,
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 |
|---|---|---|
| olfactory rehabilitationOlfactory rehabilitation consists of smelling 4 scents twice a day using scent sticks, for 12 weeks | Other | Patients with stroke and olfaction disorder benefiting from specific olfaction training. |
Primary outcome
TDI score obtained in SST after the training period (12 weeks)
Time frame: 3 months
7 secondary outcomes
Score obtained on the ASOF quality of life questionnaire modified after training (12 weeks)
Time frame: 3 months
T, D and I sub-scores obtained in SST after training (12 weeks)
Time frame: 3 months
Number of complaints about side effects and possible discomfort related to training
Time frame: 3 months and 6 months
Number of training stops (training < 12 weeks)
Time frame: 3 months
score obtained in the SST after training (12 weeks)
Time frame: 3 months
TDI score obtained at SST 3 months after the end of training (at 24 weeks)
Time frame: 6 months
Percentage of patients changing category according to the thresholds validated by the SST (anosmia, hyposmia, normosmia).
Time frame: 3 months and 6 months
Results and safety
The study was stopped early (reason given: lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olfactory rehabilitation in people with Adult With Stroke and Olfaction's Complaint, run by University Hospital, Caen 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 11 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: stopped early, as of the sponsor's last update on 25 Jul 2025. 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?
The study was stopped early (reason given: lack of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TDI score obtained in SST after the training period (12 weeks) (time frame: 3 months). 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 25 Jul 2025.