Comparing Oral and Nasal Feeding Methods for Patients with Cerebral Small Vessel Disease
A Randomized Controlled Study to Explore the Clinical The Effect of Oral and Nasal Feeding on Cerebral Small Vessel Disease
This study is testing whether feeding patients with Cerebral Small Vessel Disease through their mouth using a special tube is better than using a tube through their nose, to see which method helps them eat better and feel healthier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | People's Hospital of Zhengzhou University Academic / other |
| Locations | 1 site (Ratchaburi) |
| Trial ID | NCT06248892 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Intermittent Oro-esophageal Tube Feeding (IOE) compared to Nasogastric Tube Feeding (NGT) in patients with Cerebral Small Vessel Disease (CSVD) who experience dysphagia. A total of 60 patients will be randomly assigned to receive either IOE or NGT while undergoing comprehensive rehabilitation therapy. The study will assess various outcomes including dysphagia improvement, nutritional status, quality of life, and incidence of pneumonia. The goal is to determine if IOE offers advantages over NGT in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 70 with a clinical diagnosis of Cerebral Small Vessel Disease and dysphagia who can cooperate with treatment.
Not a fit: Patients with dysphagia due to other cerebrovascular or neurodegenerative diseases, or those with severe comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective feeding method for patients with dysphagia due to CSVD, improving their overall health and quality of life.
How similar studies have performed: Previous studies have shown that alternative feeding methods can improve outcomes in similar patient populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of Cerebral Small Vessel Disease; * Must be able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) ; * Clinical diagnosis of dysphagia through the Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS); * Age between 40 and 70 years; * Enteral nutrition support was required and feasible. * No history of prior stroke. Exclusion Criteria: * Dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases; * Complicated with severe liver and kidney failure, tumors, or hematological disorders; * Simultaneously need to undergo other therapy that might affect the outcomes of this study; * Pregnant or nursing females.
Where this trial is running
Ratchaburi
- Ratchaburi Center Hos. — Ratchaburi, Thailand (Recruiting)
Study contacts
- Principal investigator: Nieto Luis, Master — Site Coordinator of United Medical Group located in Miami
- Study coordinator: Zhefeng Wang, Master
- Email: zhengzhouzhj@qq.com
- Phone: 19501376864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.