The Effect of Fascial Mobilization Along the Course of the Vagus Nerve on Acute Physiological Parameters in Patients With Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure (mmHg)
研究概览
简要总结
This randomized controlled trial was designed to investigate the effects of fascial mobilization along the course of the vagus nerve on acute physiological parameters in individuals with obstructive sleep apnea syndrome (OSAS). Patients diagnosed with moderate to severe OSAS by polysomnography at Mardin Training and Research Hospital Sleep Laboratory will be included in the study. Participants will be randomly assigned to mobilization or control groups. In the mobilization group, 16 minutes of manual fascial mobilization will be applied to fascial regions associated with the vagus nerve, starting from the occipitomastoid suture and extending through the cervical, thoracic, and abdominal regions. The control group will rest in the supine position for the same duration. Heart rate, systolic and diastolic blood pressure, and peripheral oxygen saturation (SpO₂) will be recorded before and after the intervention. This study is expected to demonstrate the effectiveness of fascial mobilization as a non-invasive, low-cost, and innovative approach in the treatment of OSAS, contributing to clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were blinded to group allocation. Physiotherapists performing the mobilization were not involved in the measurement process. A different physiotherapist, who was unaware of the participants' group assignments, recorded heart rate, blood pressure, and oxygen saturation before and after the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with moderate to severe obstructive sleep apnea syndrome (OSAS) confirmed by polysomnography (PSG) according to international criteria (AASM - American Academy of Sleep Medicine) with an apnea-hypopnea index (AHI ≥15/hour).
- •Patients aged between 18 and 65 years.
- •Patients able to comply with PSG procedures and the manual mobilization protocol.
- •Patients with stable cardiac and respiratory status.
- •Patients without acute exacerbations or decompensated disease.
- •Patients who have not received CPAP, BiPAP, oral appliance therapy, or surgical treatment previously, or who discontinued such treatments at least 3 months prior to enrollment.
- •Patients not taking medications that directly affect sleep patterns or autonomic nervous system function (e.g., sedatives, hypnotics, anticholinergics).
- •Patients who provide written informed consent to participate in the study.
排除标准
- •Patients with uncontrolled hypertension.
- •Patients with advanced heart failure, severe arrhythmia, or asthma.
- •Patients with coronary artery disease.
- •Patients with a history of cerebrovascular disease.
- •Patients with chronic obstructive pulmonary disease (COPD).
- •Patients with interstitial lung disease.
- •Patients with epilepsy, Parkinson's disease, or dementia.
- •Patients with major depressive disorder or anxiety disorder.
- •Patients with a body mass index (BMI) > 40 kg/m².
- •Patients with a history of major surgery in the cervical region (e.g., thyroidectomy, cervical disc surgery) or vagus nerve injury.
- •Patients with acute infection, skin lesions, or inflammatory disease in the neck/thoracic region.
- •Patients currently using CPAP, BiPAP, or oral appliances.
- •Patients with narcolepsy, insomnia, or parasomnia.
- •Patients with alcohol use or taking sedative/hypnotic medications.
- •Patients with night-shift work schedules or irregular sleep patterns.
- •Pregnant or breastfeeding women.
- •Patients with cognitive impairment preventing adherence to the study protocol.
- •Patients with severe musculoskeletal limitations (e.g., in the cervical/thoracic region) that would prevent mobilization.
研究组 & 干预措施
Vagus Nerve Fascial Mobilization
Participants in this group will receive manual fascial mobilization along anatomical regions associated with the vagus nerve, including the occipitomastoid suture, anterior and posterior cervical regions, hyoid, sternum, diaphragm, Trigonum Labbe, and radix mesenteri. Mobilization will be applied for a total of 16 minutes using gentle manual pressure and stretching techniques by a physiotherapist. Heart rate, systolic and diastolic blood pressure, and oxygen saturation will be measured before and after the intervention.
干预措施: Vagus Nerve Fascial Mobilization (Behavioral)
Sham Control Group
Participants in this group will receive a sham procedure. The physiotherapist will place hands on the same anatomical regions for 16 minutes without applying mobilization or therapeutic pressure. No active fascial mobilization will be performed. Heart rate, systolic and diastolic blood pressure, and oxygen saturation will be recorded before and after the sham procedure.
干预措施: Vagus Nerve Fascial Mobilization (Behavioral)
结局指标
主要结局
Systolic Blood Pressure (mmHg)
时间窗: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.
Systolic blood pressure will be measured non-invasively using a bedside patient monitor. The outcome will assess changes in systolic blood pressure (mmHg) across time points to evaluate the acute effects of fascial mobilization along the vagus nerve compared with sham procedure.
Heart Rate (beats per minute)
时间窗: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.
Heart rate will be measured using a bedside patient monitor. The outcome will assess the change in beats per minute (bpm) from baseline (before intervention) to post-intervention. The measure will determine the acute effect of fascial mobilization along the vagus nerve compared with sham procedure.
Diastolic Blood Pressure (mmHg)
时间窗: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.
Diastolic blood pressure will be measured non-invasively using a bedside patient monitor. The outcome will assess changes in diastolic blood pressure (mmHg) across time points to evaluate the acute effects of fascial mobilization along the vagus nerve compared with sham procedure.
Peripheral Oxygen Saturation (SpO₂, %)
时间窗: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.
"Peripheral oxygen saturation will be measured using pulse oximetry integrated into the bedside patient monitor. The outcome will assess changes in SpO₂ (%) across time points to evaluate the acute effects of fascial mobilization along the vagus nerve compared with sham procedure."
次要结局
未报告次要终点
研究者
Engin Ramazanoglu
Assistant Professor
Mardin Artuklu University