Clinical trial NCT01860560: Non-Inferiority Trial of Acute HFT Versus nCPAP
Official title: Effect of High Flow Nasal Cannula (Flowrest®) on Mild-Moderate Sleep Disordered Breathing: A Non-Inferiority Study Versus Nasal Continuous Positive Airway Pressure (CPAP) Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mild-Moderate Obstructive Sleep Disordered Breathing
Keywords: OSA
Obstructive Sleep Apnea
High Flow Therapy
CPAP
HFT
Continuous Positive Airway Pressure
Mild OSA
Moderate OSA
Lead sponsor: Vapotherm, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 apnea / hypopnea index (AHI).

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 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.

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

Primary outcomes:
measure: AHI Change (Therapy v Baseline)
timeFrame: Acute - single night therapy exposure
Secondary outcomes:
measure: Pulse Oxygen Saturation
timeFrame: Acute single night therapy exposure
measure: Sleep Architecture (WASO, %W, N1, N2, N3, REM, SL, RL, AI)
timeFrame: Acute single night therapy exposure
measure: Respiratory Event Related Arousals
timeFrame: Acute single night therapy exposure
measure: Respiratory Disturbance Index (RDI)
timeFrame: Acute single night therapy exposure
Other outcomes:
Locations:
city: Glen Burnie
country: United States
facility: Sleep Disorders Centers of the Mid-Atlantic
state: Maryland
Study officials:
affiliation: Vapotherm, Inc.
name: George Dungan, MPhil Med
role: STUDY_DIRECTOR
References: