Nutrition Tubes on Sleep Quality in Stroke-related Dysphagia

NCT06662344 | Not Yet Recruiting

• 1 other identifier: IOE-Sleep
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

Palliation to stroke-related dysphagia continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of stroke-related dysphagia on sleep quality. This is a prospective study with patients with dysphagia after stroke. Patients enrolled are randomly divided equally into 2 groups. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Their sleep quality are compared at baseline and after study.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index

  The Pittsburgh Sleep Quality Index (PSQI) is a widely used questionnaire that assesses sleep quality and disturbances over a one-month period. It consists of 19 items that are grouped into seven components. Each component is scored from 0 to 3, with a total PSQI score ranging from 0 to 21. A higher score indicates worse sleep quality, while a lower score indicates better sleep quality. Generally, a total score of 5 or higher is considered indicative of poor sleep quality.

  day1 and day15

Study Arms (2)

Intermittent Oral-esophageal Tube Feeding+comprehensive rehabilitation therapy

EXPERIMENTAL

During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. Specifically, conventional care includes health education, dietary adjustments, nasopharyngeal hygiene, management of risk factors (blood pressure and lipid control, etc.), exercise rehabilitation, and psychological support. The frequency and content of these interventions are arranged based on the patients; health condition. The observation group receives Intermittent Oro-esophageal Tube Feeding for enteral nutrition support

Behavioral: Intermittent Oral-esophageal Tube Feeding; Behavioral: comprehensive rehabilitation therapy

Nasogastric Tube Feeding+comprehensive rehabilitation therapy

ACTIVE COMPARATOR

During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. Specifically, conventional care includes health education, dietary adjustments, nasopharyngeal hygiene, management of risk factors (blood pressure and lipid control, etc.), exercise rehabilitation, and psychological support. The frequency and content of these interventions are arranged based on the patients; health condition.The control group receives nasogastric tube for enteral nutrition support

Behavioral: Nasogastric Tube Feeding; Behavioral: comprehensive rehabilitation therapy

Interventions

Intermittent Oral-esophageal Tube Feeding BEHAVIORAL

The specific procedure was as follows: the infant was placed in a semi-recumbent or sitting position with the head fixed. Before each feeding, the infant's oral and nasal secretions were to be cleared. An intermittent oro-esophageal tube was appropriately lubricated with water on the head part. The professional medical staff held the tube and slowly inserted it through one side of the mouth into the upper part of the esophagus. The depth of insertion depended on the patient's age and height. After each feeding, the tube was immediately removed, and the patient was held upright for at least 30 minutes in case of reflux.

Intermittent Oral-esophageal Tube Feeding+comprehensive rehabilitation therapy

Nasogastric Tube Feeding BEHAVIORAL

Nasogastric Tube Feeding were used for feeding to provide nutritional support. Each feeding was administered by a nurse using the infant's mother's breast milk through the tube. The amount of each feeding varied from 20 to 100 ml depending on the age of the infant, with feedings given every 2 to 3 hours, approximately 10 times per day. The duration of each feeding procedure ranged from 10 to 20 minutes. The total daily intake ranged from 200 to 1000 ml. Each tube was kept indwelling for 5 to 7 days. When the tube needed to be replaced, it was removed after the last feeding of a day and a new tube was to be inserted through the other nostril on the following morning to continue the nutritional support.

Nasogastric Tube Feeding+comprehensive rehabilitation therapy

comprehensive rehabilitation therapy BEHAVIORAL

Both groups were given comprehensive rehabilitation therapy. The main intervention measures included: 1) non-invasive ventilator treatment, generally at least once every night and typically not exceeding continuous daily usage.; 2) attention to feeding and sleeping positions, with a recommended sleeping position of lateral recumbent and the head of the bed raised by 20-30°; 3) swallowing function training, such as tongue muscle stretching training, assisted anterior jaw protrusion training, lemon ice stimulation to the soft palate, pharyngeal wall, etc., generally 5 days per week, twice per day, 5-20 minutes each time; 4) pulmonary ultrashort wave therapy, generally at least 2-3 times a week, and not more than once a day; 5) physical therapy, such as intensive training for gross motor functions including lifting the head, turning over, sitting, crawling, standing, etc., generally 3-5 days per week, 1-2 times per day, 5-20 min each time.

Intermittent Oral-esophageal Tube Feeding+comprehensive rehabilitation therapy; Nasogastric Tube Feeding+comprehensive rehabilitation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years.
• Meeting the diagnostic criteria for ischemic stroke .
• Dysphagia confirmed by Videofluoroscopic Swallowing Study.
• Clear consciousness.
• No history of prior stroke.
• Stable vital signs.

You may not qualify if:

• Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
• Complicated with severe liver and kidney failure, tumors, or hematological disorders.
• Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
• Pregnant or nursing females.

Sponsors & Collaborators

• Babujinaya Cela: lead

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Research Director

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: November 30, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10