The Effect of Fascial Mobilization Along the Course of the Vagus Nerve on Acute Physiological Parameters in Patients With Obstructive Sleep Apnea Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Systolic Blood Pressure (mmHg)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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.
Intervention: Vagus Nerve Fascial Mobilization (Behavioral)
Outcomes
Primary Outcomes
Systolic Blood Pressure (mmHg)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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, %)
Time Frame: 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."
Secondary Outcomes
No secondary outcomes reported
Investigators
Engin Ramazanoglu
Assistant Professor
Mardin Artuklu University