Status:
WITHDRAWN
Non-Inferiority Trial of Acute HFT Versus nCPAP
Lead Sponsor:
Vapotherm, Inc.
Conditions:
Mild-Moderate Obstructive Sleep Disordered Breathing
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 a...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01860560
Start Date
May 1 2013
End Date
January 1 2014
Last Update
May 3 2023
Active Locations (1)
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1
Sleep Disorders Centers of the Mid-Atlantic
Glen Burnie, Maryland, United States, 21061