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NCT Number: NCT07122037

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cognitive Aging Anosmia Hyposmia Nervous System Diseases Neurologic Manifestations Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Total Laryngectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU UCL Namur Site Godinne

Yvoir, 5530, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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.

Primary outcomes

  1. Olfactory function

    Time frame: 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.

  2. Olfactory-related quality of life

    Time frame: 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 outcomes

  1. Olfactory bulb volume

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital of Mont-Godinne

Other

Registry information

Official study title

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

Acronym: OLFAC-TL

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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