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

NCT ID: NCT07122037

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-07

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cognitive Aging Hyposmia Total Laryngectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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NAIM + OT

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

Group Type EXPERIMENTAL

DosMedical Smell Training Set

Intervention Type 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

Intervention Type 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

Total laryngectomy patients receiving olfactory rehabilitation only with the NAIM maneuver

Group Type ACTIVE_COMPARATOR

Nasal Airflow Inducing Maneuver

Intervention Type 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.

Interventions

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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

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Mont-Godinne

OTHER

Sponsor Role lead

Responsible Party

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Nève Jean-Gualbert

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU UCL Namur Site Godinne

Yvoir, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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52/2021

Identifier Type: -

Identifier Source: org_study_id

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