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

Not Applicable

Active, not recruiting

• Conditions: Cognitive Aging; Hyposmia; Total Laryngectomy

• Registration Number: NCT07122037
• Lead Sponsor: University Hospital of Mont-Godinne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-07
• Study First Submitted: 2025-07-24
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-10
• Last Update Submitted: 2025-08-10
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2025-09
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Olfactory function	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.
Olfactory-related quality of life	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 Outcome Measures

Name	Time	Method
Olfactory bulb volume	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.

Trial Locations

Locations (1)

CHU UCL Namur Site Godinne; 🇧🇪 Yvoir, Belgium