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:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT01241604
Eligibility Criteria:
Inclusion Criteria:
* Age 21-80.
* Ability to provide consent.
* Documentation of medical stability by investigator.
* Currently using BiPAP S/T (At least 4 weeks on therapy).
* Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration.
Exclusion Criteria:
* Participants, who are acutely ill, medically complicated or who are medically unstable.
* Participants in whom PAP therapy is otherwise medically contraindicated.
* Participants who are unwilling to wear PAP.
* Participants who are currently prescribed oxygen therapy.
* Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).
* Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
* Participants with untreated, non-obstructive sleep apnea (OSA)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome Periodic Limb Movement (PLM) Arousal Index \> 15).
* Participants who are unwilling to participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT01241604
Study Brief:
Protocol Section:
NCT01241604