Intermittent Oral Tube in Alzheimer's Patients

Copka Sonpashan

Status: Not yet enrolling

Conditions: Alzheimer Disease

Treatments: Device: Nasogastric tube; Device: Intermittent Oral-esophageal Tube Feeding; Behavioral: Conventional Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06328829

IOE Alzheimer

Details and patient eligibility

About

This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.

Full description

The Alzheimer's disease in the elderly exhibits the high prevalence.This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 18 years and 85 years, meeting the diagnosis of Alzheimer's Disease.
• presence of no contraindication for enteral nutrition.
• with dysphagia verified by Imaging materials.
• with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications
• Minimum Mental State Examination ranging from 10-26

Exclusion criteria

• unable to cooperate in completing treatment and assessment due to personal reasons or other disorders.
• complicated with other intracranial lesions, such as stroke.
• abnormal structure of swallowing-related organ and tissue.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Conventional Care+Intermittent Oral-esophageal Tube Feeding

Experimental group

Description:

During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The observation group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support

Treatment:

Behavioral: Conventional Care

Device: Intermittent Oral-esophageal Tube Feeding

Conventional Care+Nasogastric tube

Active Comparator group

Description:

During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The control group receives Nasogastric Tube Feeding for enteral nutrition support

Treatment:

Behavioral: Conventional Care

Device: Nasogastric tube