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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
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult With Stroke and Olfaction's Complaint

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 7, 2021
    Last Updated
    July 27, 2021
    Sponsor
    University Hospital, Caen
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    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

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    REEDUCATION OF OLFACTORY DISORDERS AFTER A CEREBRAL VASCULAR ACCIDENT IN ADULTS

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