ELECTROVEST: Electro-Stimulation Vibratory Vest for Pulmonary Rehabilitation in Patients With Chronic Respiratory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Volume of Expectorated Sputum
研究概览
简要总结
This study will evaluate the effectiveness, safety, and tolerability of a novel wearable device, the ELECTROVEST, designed to improve airway clearance in patients with chronic respiratory diseases. The ELECTROVEST will integrate high-frequency chest wall oscillation (HFCWO) with surface neuromuscular electrostimulation. This crossover clinical trial will compare the performance of the ELECTROVEST with a standard HFCWO vest (The Vest®) in adult patients. Primary outcomes will include sputum expectoration and patient-reported comfort. The study will aim to determine whether this new system can optimize bronchial hygiene.
详细描述
This is a prospective, crossover pilot study designed to evaluate the safety, efficacy, and tolerability of a novel respiratory therapy device, ELECTROVEST, in adult patients diagnosed with chronic respiratory diseases featuring bronchial hypersecretion, such as COPD, bronchiectasis, cystic fibrosis, and asthma.
ELECTROVEST is a wearable vest that integrates high-frequency chest wall oscillation (HFCWO) with surface neuromuscular electrical stimulation (NMES). This dual-action therapy aims to enhance airway clearance while also stimulating respiratory musculature.
The study will enroll 20 patients, using a non-probabilistic, intentional sampling strategy. Each participant will undergo two intervention phases, acting as their own control. The phases are separated by a 30-day washout period to minimize carryover effects.
Phase 1 (ELECTROVEST intervention): Participants receive standard fluid and aerosol therapy followed by vibratory therapy delivered by the ELECTROVEST device. Sessions include:
Warm-up phase: 2 minutes at 4 Hz
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. No masking was applied to participants, care providers, investigators, or outcome assessors due to the nature of the interventions.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Chronic Respiratory Diseases Diagnosed with chronic respiratory disease with bronchial hypersecretion: COPD, cystic fibrosis, bronchiectasis, or asthma
- •Age >16 years
- •Clinically stable (no exacerbations in past 4 weeks)
排除标准
- •Risk of pneumothorax and/or barotrauma
- •Risk or history of hemoptysis
- •On active waiting list for lung transplant or surgery
- •Musculoskeletal or other limiting condition
- •Diagnosis of osteoporosis
研究组 & 干预措施
ELECTROVEST Intervention
Participants in this arm will receive airway clearance therapy using the ELECTROVEST, a wearable device that combines high-frequency chest wall oscillation (HFCWO) with surface neuromuscular electrostimulation (EEM). The intervention will be administered alongside standard fluid and aerosol therapy. This phase is designed to evaluate the device's safety, effectiveness, and tolerability.
干预措施: ELECTROVEST (Device)
Standard HFCWO Therapy (Control)
Participants in this arm will receive standard airway clearance therapy using a high-frequency chest wall oscillation (HFCWO) vest device, either The Vest® Model 105 or the AffloVest®. The therapy will be combined with fluid and aerosol therapy and will serve as the comparator for evaluating the ELECTROVEST intervention. Participants will undergo this treatment after a 30-day washout period.
干预措施: The Vest® Model 105 (Device)
结局指标
主要结局
Volume of Expectorated Sputum
时间窗: Immediately post-intervention (within 1 hour)
Total sputum weight (in grams) collected during and within 1 hour after each airway clearance session
Discomfort Level (VAS Score)
时间窗: Immediately after each intervention session
Subjective discomfort assessed using a 0-10 visual analogue scale (VAS), where 0 indicates no discomfort and 10 indicates maximum discomfort.
次要结局
- Maximal Expiratory Pressure (PEmax)(Baseline and 24-48 hours after each intervention.)
- Six-Minute Walk Distance (6MWD)(Baseline and 24-48 hours after each intervention.)
- Forced Expiratory Volume in 1 Second (FEV1)(Baseline and 24-48 hours after each intervention.)
- Maximal Inspiratory Pressure (PImax)(Baseline and 24-48 hours after each intervention.)
- DLCO (Diffusing Capacity for Carbon Monoxide)(Baseline and 24-48 hours after each intervention.)
- Inflammatory and Muscle Biomarkers(Baseline and 24-48 hours after each intervention.)
- Maximal Nasal Inspiratory Pressure (SNIP)(Baseline and 24-48 hours after each intervention.)
- Estimated Glomerular Filtration Rate (eGFR)(Baseline and 24-48 hours after each intervention.)
- Health-Related Quality of Life (CASA-Q)(Baseline and 24-48 hours after each intervention.)
研究者
Rafael Rivilla Rivilla
Physiotherapist - Clinical Researcher
Hospitales Universitarios Virgen del Rocío