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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAIM + OT | Experimental | Total laryngectomy patients receiving olfactory rehabilitation with NAIM maneuver and olfactory training |
|
| NAIM | Active Comparator | Total laryngectomy patients receiving olfactory rehabilitation only with the NAIM maneuver |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DosMedical Smell Training Set | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From total laryngectomy to the end of olfactory rehabilitation at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU UCL Namur Site Godinne | Yvoir | 5530 | Belgium |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 21, 2025 | |
| Reset | Sep 11, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 21, 2025 | Sep 11, 2025 |
| ID | Term |
|---|---|
| D000086582 | Anosmia |
| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Nasal Airflow Inducing Maneuver | Behavioral | 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. |
|
| Pre-operatively and 6 months after total laryngectomy |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |