Cognitive Aging, Hyposmia, Total Laryngectomy
Conditions
Keywords
Anosmia, Hyposmia, Total laryngectomy, Quality of life, Olfactory bulb volume, Sniffin' Sticks Test, NAIM
Brief summary
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.
Interventions
DEVICEDosMedical 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
BEHAVIORALNasal 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.
Sponsors
University Hospital of Mont-Godinne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Olfactory function | From total laryngectomy to the end of olfactory rehabilitation at 1 year | 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. |
| Olfactory-related quality of life | From total laryngectomy to the end of olfactory rehabilitation at 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Olfactory bulb volume | Pre-operatively and 6 months after total laryngectomy | 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. |
Countries
Belgium
Outcome results
None listed