- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01270204
The Effect of Food Taste, Temperature, and Viscosity on Swallowing Efficiency
Visão geral do estudo
Status
Condições
Descrição detalhada
Swallowing problems (dysphagia) are encountered frequently in primary practice and in the hospital setting. The list of possible causes is large, ranging from strokes and neurological disease to complications of cancer treatment, acid reflux, and surgery. Many patients have a reduced ability to feel food and fluid (reduced sensation) within the throat (pharynx) and this leads to an inability to manipulate food and fluids in the correct manner. This can produce a variety of swallowing problems such as choking on foods and fluids, regurgitation, aspiration, weight loss, malnutrition and poor quality of life.
Treatment of dysphagia is largely directed at rehabilitation of muscle power and education about safe swallowing techniques or positioning that limits food and fluid from entering the airway. One of the most widely accepted treatments of dysphagia is to alter the texture of food. Most patients with dysphagia will have more difficulty swallowing thin liquids. By adding a thickener to the liquid, a food bolus becomes more cohesive, and is less likely to become aspirated. Various types of thickening products are available over-the-counter without a prescription. These thickening products are bland and currently have no flavor. We hypothesize that alterations in food taste (sweet, salty, etc…), viscosity, and temperature, will improve swallowing efficiency. The purpose of this investigation is to evaluate the effects of food taste, texture, and temperature on swallowing efficiency. The goal is to develop safer, better tasting food products and improve the quality of life in patients with disabling swallowing disorders.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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California
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Sacramento, California, Estados Unidos, 95817
- UC Davis Department of Otolaryngology
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
Normal Volunteers:
- Older than 55 years of age
- No history of voice, swallowing, reflux, or progressive neurologic disease affecting the swallowing mechanism.
- A normal self-administered dysphagia questionnaire (EAT-10 score of less than three)
Patients with Dysphagia
- Older than 55 years of age
- Patients with the following condition: Dysphagia, globus, gastroesophageal reflux, or any other condition requiring referral for a dynamic swallowing study.
- Patients willing to provide written informed consent for their participation in the study.
Exclusion Criteria:
- Patients unable to complete the administration of the full taste and viscosity protocol.
- Patients with profound dysphagia unable to safely consume the test solutions.
- Patients with known sensitivities or allergies to any of the test solutions.
- Patients who are prisoners.
- Patients have a history of diabetes.
- Patients who are unable to follow the simple instructions to swallow the test solutions on instruction and answer the questionnaire.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Controle de caso
- Perspectivas de Tempo: Transversal
Coortes e Intervenções
Grupo / Coorte |
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Normal Volunteers
Patients older than 55 years of age with no history of voice, swallowing, reflux, or progressive neurologic disease affecting the swallowing mechanism.
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Patients with Dysphagia
Patients older than 55 years of age with the following condition: Dysphagia (the sensation of swallowing difficulty), globus, gastroesophageal reflux, or any other condition requiring referral for a dynamic swallowing study.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Swallowing amplitude as measured on digital accelerometry.
Prazo: Measurement is made at the time of patient participation.
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Digital accelerometry is a non-invasive method of measuring swallowing efficiency.
A surface sensor is taped to the skin over the region of the thyroid prominence.
When the patient swallows, the sensors measures upward acceleration of the thyroid cartilage and a measurement of swallowing amplitude, a surrogate measure for swallowing efficiency, is obtained.
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Measurement is made at the time of patient participation.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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To evaluate swallowing efficiency.
Prazo: Measurement is taken at the time of patient participation.
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Peak pharyngeal pressure, upper esophageal sphincter (UES) residual pressure, and UES relaxation time, all surrogate measure sof swallowing efficiency, will be measured using pharyngeal manometry.
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Measurement is taken at the time of patient participation.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 201018116
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