Mechanical and Sensorial Training in the Olfactive Rehabilitation of Patients With Total Laryngectomy : a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Olfactory function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Olfactory function
时间窗: 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
时间窗: 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.
次要结局
- Olfactory bulb volume(Pre-operatively and 6 months after total laryngectomy)
研究者
Nève Jean-Gualbert
Medical Doctor
University Hospital of Mont-Godinne