Status:
ENROLLING_BY_INVITATION
Fascial Mobilization Along the Vagus Nerve and Its Effects on Acute Physiological Parameters in Obstructive Sleep Apnea
Lead Sponsor:
Mardin Artuklu University
Conditions:
Obstructive Sleep Apnea Syndromes
Eligibility:
All Genders
18-65 years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07169058
Start Date
August 1 2025
End Date
December 12 2025
Last Update
September 11 2025
Active Locations (1)
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1
Mardin Artuklu University
Mardin, Mardin, Turkey (Türkiye), 47000