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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT07149233
Eligibility Criteria:
Inclusion Criteria:
* Male or female participants
* Age between 18 and 70 years
* Clinical diagnosis of moderate to severe Obstructive Sleep Apnea (OSA), confirmed by polysomnography
* Not currently undergoing treatment for OSA
Exclusion Criteria:
* Presence of neuromuscular disorders, infectious diseases, immunological conditions, tumors, or any disease that prevents inspiratory muscle training (IMT), manovacuometry, or respiratory muscle performance assessment
* Unstable angina, untreated or uncontrolled systemic arterial hypertension, left ventricular dysfunction, cerebral aneurysm, or any cardiovascular condition contraindicating IMT or respiratory muscle testing
* Upper limb deformities that prevent the use of actigraphy devices or oximetry sensors
* Other sleep disorders (e.g., insomnia, hypoventilation syndrome, or need for continuous home oxygen therapy)
* Cognitive impairment that limits the participant's ability to understand or follow study procedures
* Ongoing or planned CPAP therapy during the follow-up period
* Participation in a pulmonary rehabilitation program within 6 months prior to the study
* Moderate or high physical activity level according to the IPAQ, including regular moderate or vigorous physical activity within the past 30 days
* Use of sleep-inducing medication to treat insomnia
* Grade 2 or 3 obesity (BMI ≥ 35 kg/m²)
* Residence in a geographic area with limited or no access to telephone or internet service, preventing contact or data transmission from study devices (actigraphy and/or oximetry sensors)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07149233
Study Brief:
Protocol Section:
NCT07149233