Mechanical and Sensorial Training in the Olfactive Rehabilitation of Patients With Total Laryngectomy (OLFAC-TL)

University Hospital of Mont-Godinne

Status: Active, not recruiting

Conditions: Total Laryngectomy; Cognitive Aging; Hyposmia

Treatments: Device: DosMedical Smell Training Set; Behavioral: Nasal Airflow Inducing Maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT07122037

52/2021

Details and patient eligibility

About

To assess the efficacy of two olfactory rehabilitation protocols (Nasal Airflow-Inducing Maneuver (NAIM) with or without ol-factory training) on olfactory function (sniffing stick test) and quality of life (questionnaire Self-MOQ and EORTC QLQ-H&N35) in patients with total laryngectomy.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Man or woman over 18 years of age, with no upper age limit
• Patient scheduled to total laryngectomy either for oncological purpose (treatment approved by local tumor board) or for functional purpose (se-vere chronic inhalation)
• Capacity to understand and voluntarily sign an informed consent form. Exclusion criteria
• Insufficient French language skills.
• 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

NAIM + OT

Experimental group

Description:

Total laryngectomy patients receiving olfactory rehabilitation with NAIM maneuver and olfactory training

Treatment:

Behavioral: Nasal Airflow Inducing Maneuver

Device: DosMedical Smell Training Set

NAIM

Active Comparator group

Description:

Total laryngectomy patients receiving olfactory rehabilitation only with the NAIM maneuver

Treatment:

Behavioral: Nasal Airflow Inducing Maneuver