Non-Inferiority Trial of Acute HFT Versus nCPAP

Study to evaluate the acute efficacy of a single night of High Flow Therapy (HFT) to treat
mild-moderate predominantly obstructive Sleep Disordered Breathing, as compared to nasal
Continuous Positive Airway Pressure (CPAP) therapy. Subjects will be order-randomized to
receive HFT or CPAP in the laboratory, undergo a washout period, and return for the
alternative therapy in the laboratory. The hypothesis is that HFT will be non-inferior to
CPAP in controlling Apnea/Hypopnea events in this subject set during this study.

Primary outcome will be Apnea / Hypopnea Index (AHI) change on therapy as compared to
baseline diagnostic polysomnography.

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