Non-Inferiority Trial of Acute HFT Versus nCPAP (NCT01860560) | Clinical Trial Compass
WithdrawnNot Applicable
Non-Inferiority Trial of Acute HFT Versus nCPAP
Stopped: this was an error. Study never initiated
United States0Started 2013-05
Plain-language summary
Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the management of apnea / hypopnea index (AHI).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 imp…