REEDUCATION OF OLFACTORY DISORDERS AFTER A CEREBRAL VASCULAR ACCIDENT IN ADULTS (RE-OLF)
Primary Purpose
Adult With Stroke and Olfaction's Complaint
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
olfactory rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Adult With Stroke and Olfaction's Complaint
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patients with stroke and olfaction disorder benefiting from specific olfaction training.
Patients with stroke and olfactory disorder benefiting from standard post-stroke rehabilitation
Arm Description
Outcomes
Primary Outcome Measures
TDI score obtained in SST after the training period (12 weeks)
Secondary Outcome Measures
Score obtained on the ASOF quality of life questionnaire modified after training (12 weeks)
T, D and I sub-scores obtained in SST after training (12 weeks)
Number of complaints about side effects and possible discomfort related to training
Number of training stops (training < 12 weeks)
score obtained in the SST after training (12 weeks)
TDI score obtained at SST 3 months after the end of training (at 24 weeks)
Percentage of patients changing category according to the thresholds validated by the SST (anosmia, hyposmia, normosmia).
Full Information
NCT ID
NCT04703218
First Posted
January 7, 2021
Last Updated
July 27, 2021
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT04703218
Brief Title
REEDUCATION OF OLFACTORY DISORDERS AFTER A CEREBRAL VASCULAR ACCIDENT IN ADULTS
Acronym
RE-OLF
Official Title
REEDUCATION OF OLFACTORY DISORDERS AFTER A CEREBRAL VASCULAR ACCIDENT IN ADULTS
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult With Stroke and Olfaction's Complaint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with stroke and olfaction disorder benefiting from specific olfaction training.
Arm Type
Experimental
Arm Title
Patients with stroke and olfactory disorder benefiting from standard post-stroke rehabilitation
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
olfactory rehabilitation
Intervention Description
Olfactory rehabilitation consists of smelling 4 scents twice a day using scent sticks, for 12 weeks
Primary Outcome Measure Information:
Title
TDI score obtained in SST after the training period (12 weeks)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Score obtained on the ASOF quality of life questionnaire modified after training (12 weeks)
Time Frame
3 months
Title
T, D and I sub-scores obtained in SST after training (12 weeks)
Time Frame
3 months
Title
Number of complaints about side effects and possible discomfort related to training
Time Frame
3 months and 6 months
Title
Number of training stops (training < 12 weeks)
Time Frame
3 months
Title
score obtained in the SST after training (12 weeks)
Time Frame
3 months
Title
TDI score obtained at SST 3 months after the end of training (at 24 weeks)
Time Frame
6 months
Title
Percentage of patients changing category according to the thresholds validated by the SST (anosmia, hyposmia, normosmia).
Time Frame
3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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,
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.
12. IPD Sharing Statement
Learn more about this trial
REEDUCATION OF OLFACTORY DISORDERS AFTER A CEREBRAL VASCULAR ACCIDENT IN ADULTS
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