Fascial Mobilization Along the Vagus Nerve and Its Effects on Acute Physiological Parameters in Obstructive Sleep Apnea

Official title

The Effect of Fascial Mobilization Along the Course of the Vagus Nerve on Acute Physiological Parameters in Patients With Obstructive Sleep Apnea Syndrome

Overview

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.

Interventions

• Behavioral Vagus Nerve Fascial Mobilization
  Reference Points of the Body Regions for Mobilization 1. Occipito-Mastoid Suture (OM) The occipitomastoid suture is the cranial suture located between the occipital bone and the mastoid part of the temporal bone. The condylus squamosa mastoidea serves as the pivot point. The patient lies in the supine position while the physiotherapist sits at the head of the patient. One hand is placed under the occiput at the suture, while the other hand is placed on the mastoid portion of the temporal bone.

Primary outcome measures

• Systolic Blood Pressure (mmHg) [Time frame: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.]
• Heart Rate (beats per minute) [Time frame: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.]
• Diastolic Blood Pressure (mmHg) [Time frame: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.]
• Peripheral Oxygen Saturation (SpO₂, %) [Time frame: Baseline (pre-intervention), immediately post-intervention, 5 minutes post-intervention, and 15 minutes post-intervention.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Mardin Artuklu University — Mardin

Publications

• Delaney JP, Leong KS, Watkins A, Brodie D. The short-term effects of myofascial trigger point massage therapy on cardiac autonomic tone in healthy subjects. J Adv Nurs. 2002 Feb;37(4):364-71. doi: 10.1046/j.1365-2648.2002.02103.x. PMID 11872106
• Austelle CW, Cox SS, Wills KE, Badran BW. Vagus nerve stimulation (VNS): recent advances and future directions. Clin Auton Res. 2024 Dec;34(6):529-547. doi: 10.1007/s10286-024-01065-w. Epub 2024 Oct 4. PMID 39363044

Identifiers

NCT: NCT07169058 · 2025/2-11

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗