Evaluation of the Transcutaneous Vagal Nerve Stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty, Sleep Quality, and Inflammation in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of the transcutaneous vagal nerve stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty
研究概览
简要总结
This clinical study, conducted at the Techirghiol Balneary and Rehabilitation Sanatorium, aims to evaluate the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in improving clinical and biological parameters associated with frailty in older adults. Over a two-week period, participants aged over 60 years, without dementia, cardiac pacemakers, or auditory implants, will be assigned to two groups: an intervention group receiving active taVNS and a control group receiving sham stimulation. Both groups will undergo individualized medical rehabilitation therapies according to their clinical needs.
The study will assess frailty using the Edmonton Frailty Scale, sleep quality through the Pittsburgh Sleep Quality Index, and cognitive function with the Montreal Cognitive Assessment (MoCA) and the Rapid Cognitive Screen. Additionally, inflammatory markers (C-reactive protein, IL-6, TNF-alpha) will be measured at baseline and upon discharge.
The primary objective is to demonstrate that the intervention group will show greater improvements in cognitive scores, sleep quality, and reductions in inflammatory markers compared to the control group at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years.
- •Vertebro-peripheral osteoarthritic disease without contraindication for physiotherapy
- •Patients with cognitive capacity to understand
排除标准
- •History of major psychiatric disorders, under psychiatric medication or optimal treatment for associated symptoms.
- •Long-term use of corticosteroid or nonsteroidal anti-inflammatory drugs up to one month before the study
- •Sedative medication during hospitalization.
- •Allergies or sensitivities to electrodes or the Nurosym device.
研究组 & 干预措施
Aurical Vagus Nerve Stimulated Patients
The patients received 1h per day auricular vagus nerve stimulation and individual rehabilitation procedures
干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (Device)
Aurical Vagus Nerve Stimulated Patients
The patients received 1h per day auricular vagus nerve stimulation and individual rehabilitation procedures
干预措施: Physiotherapy (Procedure)
Sham Group - Non stimulated patients
These patients only received individual rehabilitation procedures
干预措施: Physiotherapy (Procedure)
结局指标
主要结局
Evaluation of the transcutaneous vagal nerve stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty
时间窗: From enrollment to the end of treatment at 10 days - MOCA-B and RCS test The Edmonton Frailty Scale was only used at admission as a reference measure of frailty status because meaningful changes in frailty status typically require longer time intervals.
Investigation of AVNT effect on cognitive frailty using the Montreal Cognitive Assessment (MoCA-B), Edmonton Frailty Scale, and Rapid Cognitive Screen Test (RCS). Every one of the test is measured in units of a scale. For Montreal Cognitive Assessment - Basic (MoCA-B) the total Score is 30 points. A score ≥ 26 is generally considered within normal limits Scores \< 26 may suggest mild cognitive impairment (MCI). \< 20 may suggest moderate cognitive impairment. In this study, we calculated both the total MoCA-B score and separate domain-specific scores to identify domain-level changes more precisely. The Rapid Cognitive Test is a brief screening instrument used to detect mild cognitive impairment and early dementia. Maximum score:10 ; ≤5: Suggestive of dementia For the Edmonton Frail Scale (EFS), the scoring system is: Total score range: 0-17; Higher scores indicate greater frailty. It was administered only at baseline (upon admission) as a reference measure of frailty status.
次要结局
- Effects of AVNT (Trans-auricular vagus nerve stimulation) therapy on sleep quality(We performed 2 measurements on day 1 and one on the final day (day 10))
研究者
Elena-Valentina Ionescu
Assit. Prof. Dr. Ionescu Elena Valentina
Balnear and Rehabilitation Sanatorium Techirghiol