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NCT Number: NCT06662344

Nutrition Tubes on Sleep Quality in Stroke-related Dysphagia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study lasts 15 days for each patient. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: day1 and day15

    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.

Sponsors and collaborators

Lead sponsor

Babujinaya Cela

Other Gov

Registry information

Official study title

A Randomly Controlled Study to Explore the Effect of Oral Tube Feeding on Sleep Quality in Stroke-related Dysphagia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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