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NCT Number: NCT07169058

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mardin Artuklu University

Mardin, 47000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vagus Nerve Fascial Mobilization

Behavioral

Reference Points of the Body Regions for Mobilization

  • 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. The patient's head is turned toward the direction of mobilization, and mobilization is performed using the weight of the head (25). Each application is planned as a single repetition lasting 120 seconds.
  • Anterior Cervical Region (Triangle) Topographically, this region is located at the anterior part of the neck, extending along the seven cervical vertebrae (C1-C7). The anterior triangle is bordered superiorly by the lower margin of the mandible, laterally by the anterior median line of the s

Other names: 1

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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."

Sponsors and collaborators

Lead sponsor

Mardin Artuklu University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 11, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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