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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT01860560
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Previous diagnosis of primarily obstructive mild-moderate Sleep Disordered Breathing during in-laboratory polysomnography
* Ability to read and understand English Language
* Ability to provide informed consent
Exclusion Criteria:
* Unstable medical illness within the last month (30 days)
* Acute / recent upper airway infection
* Prior use of non-continuous positive airway pressure medical technology therapies prescribed by a physician for the management of obstructive sleep disordered breathing (e.g., Provent®, Winx™, mandibular advancement oral appliances, etc.)
* Prior use or exposure to CPAP / Bi-Level / or other non-invasive ventilatory modalities
* Craniofacial or other anatomical anomalies that may predispose patients to upper airway obstruction, or obvious blockage to nasal air flow
* Patients using opioids or amphetamines will be excluded from the study.
* Enhanced oxygen requirement (i.e., FiO2\>0.21)
* Patients requiring Bi-Level therapy upon CPAP titration attempt
* Surgery since the diagnostic PSG
* Significant recent sedative/hypnotic use likely, in the opinion of the principle investigator, to impair ventilatory control or impact the subsequent titration of either CPAP therapy or Flowrest therapy (including benzodiazepines, antihistamines, imidazopyridines)
* Significant use of stimulant medications likely, in the opinion of the principle investigator, likely to alter ventilatory or upper airway control and impact the subsequent titration of either CPAP therapy or Flowrest therapy (including amphetamines, high dose caffeine, etc.)
* Significant neurologic or cardiac pathology likely to seriously impact respiratory effort or ventilatory control (e.g., post CVA with ventilatory impairment)
* Presence of significant sleep disorders likely to induce hypersomnolence or interfere with the ability to titrate CPAP therapy or Flowrest therapy (including narcolepsy, PLMS/RLS, severe chronic insomnia, non-OSA obesity hypoventilation syndrome, etc.)
* Unsuitable for inclusion in the opinion of the investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01860560
Study Brief:
Protocol Section:
NCT01860560