Recruiting soon

Oral Tube Feeding for Sleep Quality in Stroke-related Dysphagia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Intermittent Oral-esophageal Tube Feeding

+ comprehensive rehabilitation therapy

+ Nasogastric Tube Feeding

Behavioral
Who is being recruted

Deglutition Disorders+3

+ Digestive System Diseases

+ Esophageal Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: November 2024
See protocol details

Summary

Principal SponsorBabujinaya Cela
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 30, 2024

Actual date on which the first participant was enrolled.

This study focuses on improving sleep quality for patients who have trouble swallowing after a stroke, a condition known as dysphagia. While nasogastric tube feeding is commonly used to help with nutrition in these patients, it has certain drawbacks that need addressing. The research looks into whether a different method, called intermittent oro-esophageal tube feeding, can provide better results. By examining this new approach, the study aims to offer a potential solution that could enhance patient care and tackle ongoing challenges in managing stroke-related dysphagia. Participants in the study are stroke patients who have difficulty swallowing. They are randomly assigned to one of two groups: one group receives the new feeding method, the intermittent oro-esophageal tube feeding, while the other group continues with the traditional nasogastric tube feeding. Each participant is monitored over 15 days, during which their sleep quality is assessed at the beginning and end of the study. By comparing the sleep quality between the two groups, researchers hope to determine which feeding method might be more effective in improving rest for these patients. This study does not specifically mention risks or benefits, but it is designed to find a better way to support nutrition and sleep for those who need it.

Official TitleA Randomly Controlled Study to Explore the Effect of Oral Tube Feeding on Sleep Quality in Stroke-related Dysphagia
NCT06662344
Principal SponsorBabujinaya Cela
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

140 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Deglutition DisordersDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesOtorhinolaryngologic DiseasesPharyngeal Diseases

Criteria

6 inclusion criteria required to participate
Age>18 years.
Meeting the diagnostic criteria for ischemic stroke .
Dysphagia confirmed by Videofluoroscopic Swallowing Study.
Clear consciousness.
Show More Criteria
4 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
Recruiting soonNo study centers