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

Mechanical and Sensorial Training in the Olfactive Rehabilitation of Patients With Total Laryngectomy : a Randomized Controlled Study

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 Overview

• Status: Active, not recruiting
• Conditions: Cognitive Aging; Hyposmia; Total Laryngectomy
• Intervention / Treatment: Device: DosMedical Smell Training Set; Behavioral: Nasal Airflow Inducing Maneuver

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Yvoir, Belgium, 5530
    • CHU UCL Namur Site Godinne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAIM + OT; Total laryngectomy patients receiving olfactory rehabilitation with NAIM maneuver and olfactory training	Device: 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; Behavioral: 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.
Active Comparator: NAIM; Total laryngectomy patients receiving olfactory rehabilitation only with the NAIM maneuver	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Pre-operatively and 6 months after total laryngectomy

Collaborators and Investigators

• Sponsor: University Hospital of Mont-Godinne

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 24, 2025
• First Submitted That Met QC Criteria: August 10, 2025
• First Posted (Actual): August 14, 2025

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 10, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Hyposmia; Anosmia; Total laryngectomy; Olfactory bulb volume; Sniffin&#39; Sticks Test; NAIM
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Sensation Disorders; Olfaction Disorders; Anosmia
• Other Study ID Numbers: 52/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No