NCT04741581已完成不适用
Effect on Swallowing Function As Assessed by a Videofluoroscopy (VFS) One Day Study with Bolus of Various Viscosities, Followed, in a Subset of Patients, by an Acceptability 14 Days Study Combined with an Exploratory Hydration Assessment Study At a Prescribed Viscosity.
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The United Kingdom Advisory Committee on Borderline Substances (UK ACBS)
研究概览
简要总结
Evaluation of swallowing function and hydration following consumption of ThickenUp® Gel Express in patients with dysphagia.
详细描述
ThickenUp® Gel Express for Patients With Dysphagia ("Hydra-01 Study"): Effect on Swallowing Function as Assessed by a Videofluoroscopy (VFS) One Day Study With Bolus of Various Viscosities (Study Part 1) and Followed, in a Subset of Patients, by a United Kingdom Advisory Committee on Borderline Substances (UK ACBS) Acceptability 14 Days Study Combined With an Exploratory Hydration Assessment Study at a Prescribed Viscosity (Study Part 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •(for study part 1 and part 2):
- •Aged ≥ 18 years;
- •Diagnosed with oropharyngeal dysphagia and with a documented impaired safety of swallow by V-VST and PAS >1 during VFS;
- •History and/or current of swallowing difficulties;
- •Willing to adhere to the restrictions specified in the protocol;
- •Must be competent to understand the nature of the study and capable of giving written informed consent. In case patients are not capable of providing written informed consent (i.e. affected by dementia) a family/legal representative could provide the consent for the study.
- •Willing to report for the scheduled study visits and communicate to study personnel about adverse events and concomitant medication use.
排除标准
- •(for study part 1 and part 2):
- •Patients suffering from idiosyncratic phenomena or who are allergic to iodinated contrast media;
- •Major respiratory disease requiring oxygen or undergoing any type of surgery in the three months prior to the study;
- •Current diarrhea, vomiting or abdominal pain;
- •Alcohol or drug dependence (based on anamnesis only);
- •COVID-19 positive patients (with or without symptoms) at the time of enrolment;
- •Patients who, in the judgment of the investigator, are likely to be noncompliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
- •Having participated in a clinical study in the last 4 weeks and received compensation beyond a certain approved and predefined limit;
- •Having a clinical condition that is contraindicated with the study product;
- •Positive urine pregnancy test at screening for women of childbearing potential;
- •Allergy towards milk, mustard, egg, or celery.
- •Additional inclusion criteria for study part 2 only:
- •Patient willing to participate in study part 2;
- •Patient/caregiver able to record daily GI symptoms, compliance and fluid intake;
- •Patient able to respond to acceptability questionnaire (organoleptic properties, texture, appearance).
- •Patient willing to only use study product as the sole thickening agent during the Part
- •Additional exclusion criteria for study part 2 only:
- •Undergone a major gastrointestinal surgery less than 3 months prior to enrolment in this study;
- •Obstruction of the gastrointestinal tract.
结局指标
主要结局
The United Kingdom Advisory Committee on Borderline Substances (UK ACBS)
时间窗: 14 days
Part 2
Penetration-Aspiration Score (PAS)
时间窗: 1 day
Part 1 -Bolus penetration into the laryngeal vestibule (PAS Score): the maximum PAS score across the different boluses assessed during videofluoroscopic (VFS) recording.
次要结局
未报告次要终点
研究者
研究点 (1)
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