Mechanical and Sensorial Training in the Olfactive Rehabilitation of Patients With Total Laryngectomy
NCT ID: NCT07122037
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
16 participants
INTERVENTIONAL
2021-09-07
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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NAIM + OT
Total laryngectomy patients receiving olfactory rehabilitation with NAIM maneuver and olfactory training
DosMedical Smell Training Set
Olfactory training with four different odorants (e.g., rose, eucalyptus, lemon, and cloves) for approximately 10 seconds each, twice a day, in the morning and in the evening
Nasal Airflow Inducing Maneuver
Repeated generation of an "underpressure" in the oral cavity by simultaneously lowering the jaw, the floor of the mouth the tongue, the base of the tongue and soft palate with securely closed lips. This negative pressure created in the oral cavity generates an airflow through the nose.
NAIM
Total laryngectomy patients receiving olfactory rehabilitation only with the NAIM maneuver
Nasal Airflow Inducing Maneuver
Repeated generation of an "underpressure" in the oral cavity by simultaneously lowering the jaw, the floor of the mouth the tongue, the base of the tongue and soft palate with securely closed lips. This negative pressure created in the oral cavity generates an airflow through the nose.
Interventions
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DosMedical Smell Training Set
Olfactory training with four different odorants (e.g., rose, eucalyptus, lemon, and cloves) for approximately 10 seconds each, twice a day, in the morning and in the evening
Nasal Airflow Inducing Maneuver
Repeated generation of an "underpressure" in the oral cavity by simultaneously lowering the jaw, the floor of the mouth the tongue, the base of the tongue and soft palate with securely closed lips. This negative pressure created in the oral cavity generates an airflow through the nose.
Eligibility Criteria
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Inclusion Criteria
* Patient scheduled to total laryngectomy either for oncological purpose (treatment approved by local tumor board) or for functional purpose (se-vere chronic inhalation)
Exclusion Criteria
* Preexistent anosmia (Sniffin' Stick test score \<16/48)
* Contraindications to MRI imaging (e.g., metallic foreign bodies, claustro-phobia…)
* Severe chronic rhinosinusitis with polyps (Davos score 3 or more)
18 Years
ALL
No
Sponsors
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University Hospital of Mont-Godinne
OTHER
Responsible Party
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Nève Jean-Gualbert
Medical Doctor
Locations
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CHU UCL Namur Site Godinne
Yvoir, , Belgium
Countries
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Other Identifiers
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52/2021
Identifier Type: -
Identifier Source: org_study_id
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