Mechanical and Sensorial Training in the Olfactive Rehabilitation of Patients With Total Laryngectomy

N/AActive Not RecruitingNCT07122037

University Hospital of Mont-Godinne16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Cognitive Aging Hyposmia Total Laryngectomy

Interventions

DosMedical Smell Training SetDEVICE

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 ManeuverBEHAVIORAL

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

CHU UCL Namur Site Godinne

Yvoir, Belgium

Outcomes

Primary Outcomes

Olfactory function

Prospectively assess the effect on olfactory function of adding olfactory training to a Nasal Airflow-Inducing Maneuver (NAIM) rehabilitation protocol after total laryngectomy. Olfactory function was measured with the Sniffin' Sticks Test battery before surgery and at 1, 3, 6, and 12 months after surgery. According to normative data, hyposmia was defined as TDI scores ranging from 16.25 to 30.5, while functional anosmia was classified as a TDI score of 16 or below.

Time frame: From total laryngectomy to the end of olfactory rehabilitation at 1 year

Olfactory-related quality of life

Prospectively assess the effect on olfactory-related quality of life of adding olfactory training to a Nasal Airflow-Inducing Maneuver (NAIM) rehabilitation protocol after total laryngectomy. Participants assessed their smell-related quality of life using the validated Self-reported Mini Olfactory Questionnaire (Self-MOQ) before surgery and at 1, 3, 6, and 12 months after surgery. Additionally, the EORTC QLQ-H\&N35 questionnaire was used, specifically its senses scale, with scoring conducted according to the EORTC scoring manual. A higher score indicated greater olfactory dysfunction in both questionnaires.

Time frame: From total laryngectomy to the end of olfactory rehabilitation at 1 year

Secondary Outcomes

Olfactory bulb volume

Investigate the impact of olfactory rehabilitation on the olfactory bulb volume after laryngectomy. Olfactory bulb volume was measured on brain magnetic resonance imaging focusing on the olfactory bulb conducted preoperatively and six months after total laryngectory using a 3 Tesla system. Olfactory bulb volumes were measured bilaterally using coronal T2-weighted images with 2 mm-thick slices and no gaps.

Time frame: Pre-operatively and 6 months after total laryngectomy

Data from ClinicalTrials.gov

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