Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT07169058
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07169058
Study Brief:
Protocol Section:
NCT07169058