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

NCT07122037 | Active Not Recruiting

• 1 other identifier: 52/2021
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Aging; Hyposmia; Total Laryngectomy

Keywords

Anosmia; Hyposmia; Total laryngectomy; Quality of life; Olfactory bulb volume; Sniffin' Sticks Test; NAIM

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Olfactory bulb volume

  Pre-operatively and 6 months after total laryngectomy

Study Arms (2)

NAIM + OT

EXPERIMENTAL

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

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

NAIM

ACTIVE COMPARATOR

Total laryngectomy patients receiving olfactory rehabilitation only with the NAIM maneuver

Behavioral: Nasal Airflow Inducing Maneuver

Interventions

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

NAIM + OT

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.

NAIM; NAIM + OT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead

Study Sites (1)

CHU UCL Namur Site Godinne

Yvoir, 5530, Belgium

Location

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 14, 2025
• Study Start: September 7, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

BE (1)