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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT04262960
Eligibility Criteria:
Inclusion Criteria:
* Age 65 to 75 years
* Previous diagnosis of OSA with AHI\> 30 events / hour
* Body mass index below 34,9 kg/m2
* Use of CPAP for more than one year, with an average duration of at least 6 hours per night, confirmed by the device's memory
* Evidence in the device that you have stopped using it previously, for at least two weeks, with no relevant symptoms
* Use of automatic CPAP device with full memory for at least one year, preferably using device model with internet data access
* Subjects physically active and willing to provide informed consent
* Subjects willing to attend visits and blood collections in series
Exclusion Criteria:
* History of myocardial infarction, stroke or transient ischemic attack (TIA) or peripheral vascular disease.
* History of chronic diseases such as diabetes mellitus ( A fasting plasma glucose (FPG) level of 152 mg/dL or A1C \> 7,5 % ), uncontrolled severe hypertension (SBP \>180 DBP \> 110), renal failure on dialysis, cancer, autoimmune or liver disease
* A significant history of medical or psychiatric disease that may decompensate with altered sleep patterns or impair participation in the trial
* Severe or unstable clinical conditions that may be exacerbated by discontinuation of CPAP (cardiac, pulmonary, renal or other organ disorders not yet treated or worsening of symptoms in the last two months, eg cardiac arrhythmias, congestive heart failure and oxygen-dependent lung disease)
* Another primary sleep disorder that requires intervention with medications.
* Patients with unusual sleep or wake habits, including shift work.
* Professional driver or who crosses paths of more than one hour driving, in which the s sleepiness can be risk of accident.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
75 Years
Study:
NCT04262960
Study Brief:
Protocol Section:
NCT04262960