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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT04713267
Eligibility Criteria:
Inclusion Criteria:
* Documented supine positional OSA (AHIsupine/AHInonsupine ≥2) with a total AHI of ≥10 events/hour
* Age ≥18 years and \<80 years
* Written informed consent documented by signature
Exclusion Criteria:
* Previous or current use of positional therapy
* Use of home oxygen therapy
* Documented hypoventilation syndrome
* Documented Cheyne-Stokes breathing
* Documented moderate-to-severe or severe obstructive lung diseases
* Chronic heart failure
* Documented active drug or alcohol abuse
* Known or suspected non-compliance
* Inability to follow the procedures of the study, e.g. due to language problems, documented psychological disorders, documented dementia, etc. of the participant
* Current professional driver or any either documented or reported previous sleep-related driving accidents
* People working with or operating heavy machinery
* Child-bearing age: female participants who are neither surgically sterilised / hysterectomised nor post-menopausal for longer than 2 years are considered as being of child bearing potential
* Documented unstable, untreated coronary or peripheral artery disease, severe hypertension or hypotension (≥180/110 or ≤90/60 mmHg)
* BMI \>40 kg/m2 or body weight \>130 kg
* Being the investigator, his/her family members, employees, or other dependent persons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04713267
Study Brief:
Protocol Section:
NCT04713267